Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Lenvatinib tablets taken orally, once daily.

The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.

This is an open-label, non-randomized, dose escalation study. Patients will be treated with lenvatinib once daily. Each four-week treatment period will be considered to be one treatment cycle. The selection of subsequent dose levels will be performed according to an accelerated design: Although initially 3 patients per dose level will be entered, the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity greater than grade 1 (except alopecia, lymphopenia and anemia).

An Open Label Dose Escalation Study Of E7080

An Open Label Phase I Dose Escalation Study Of E7080

Based on the data in assay development stage before PD biomarker analysis in study E7080-E044-101 we did not find the appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.

The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.

All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.

A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.

Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.

BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.

Eisai Inc.

Treatment-emergent adverse events were defined as AEs that emerged during treatment, having been absent at pre-treatment, or that worsened in severity relative to the pre-treatment state, or occurred within 30 days of last dose of the treatment. Only treatment-emergent AEs and SAEs were reported.

Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 0.2 mg

Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 0.4 mg

Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 0.8 mg

One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 1.6 mg

Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 3.2 mg

Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 6.4 mg

One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 12 mg

One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 12.5 mg

One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 16 mg

Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 20 mg

Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.

Lenvatinib Fasted/Fed 25 mg

Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.

Lenvatinib Fed/Fasted 25 mg

Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib (MTD Cohort) 25 mg

Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Lenvatinib 32 mg

Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Total

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population included all participants who received at least one dose of lenvatinib.

Eisai Medical Information

Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.

Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib.

ITT population included all participants who received at least one dose of lenvatinib.

Maximum Tolerated Dose (MTD)

Adverse events

Treatment-related adverse events

Serious adverse events

Treatment-related serious adverse events

Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Safety population (ITT population) included all participants who received at least one dose of lenvatinib.

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Febrile neutropenia

Proteinuria

Thrombocytopenia

Hypertension

Fatigue

ITT/ safety population included all participants who received at least one dose of lenvatinib.

Dose-limiting Toxicities (DLTs)

Nausea

Diarrhoea

Stomatitis

Vomiting

Lethargy

Dysphonia

Dry skin

Anorexia

Constipation

Headache

Abdominal pain

Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).

Lenvatinib 0.2 - 6.4 mg

Lenvatinib 12 - 20 mg

Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).

Lenvatinib 25 mg

Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).

Safety population (ITT population) included all participants who took at least one dose of lenvatinib.

Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%

Partial response

Stable disease

Progressive disease

Not evaluable

Best Overall Response (BOR)

Cycle 1 Day 1

Cycle 2 Day 1

Pharmacokinetic (PK) population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.

Maximum Plasma Concentration (Cmax) of Lenvatinib

PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.

Time to Maximum Plasma Concentration (Tmax) of Lenvatinib

Apparent Plasma Half-life (t1/2) of Lenvatinib

Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))

Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))

Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)

Apparent Volume of Distribution (Vz/F)

Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)

Renal Clearance (CLr) of Lenvatinib

Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.

Lenvatinib Fed 25 mg

Lenvatinib Fasted 25 mg

The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.

Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))

Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib

This was a pilot study and a statistical sample size calculation was not performed.

Lenvatinib Fed State 25 mg

Lenvatinib Fasted State 25 mg

Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib

No appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.

Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples

Dose Escalation (4 Weeks)

Food-Effect Pilot Study (4 Weeks)

Individual interview + Self-report questionnaire + long-term follow-up medical consultation + At 1 year : Assessment of prescription's adherence

Individual interview + Self-report questionnaire

The qualitative interview aims to identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up.

Interview

To assess the quality of life, anxiety/depression of former patients and relatives:

For child and adolescent patients (less than 15 years old at inclusion):

* Pediatric Quality of Life Inventory Cancer module
* Screen for Child Anxiety Related Emotional Disorders Revised
* Children's Depression Inventory

For patients over 15 years of age at the time of inclusion and parents:

* 36-Item Short Form Health Survey
* Hospital Anxiety and Depression Scale

To describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues: number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home.

Self-report questionnaire

To assess adherence to long-term follow-up medical consultation:

- number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation To assess medical complications through clinical data collection

Medical consultation

Veronique CHRISTOPHE, Pr

Amandine BERTRAND, MD

Cécile Conter, MD

Isabelle Ray-Coquard, MD

Perrine Marec Bérard, MD

Amandine Bertrand, MD

Pierre Leblond, MD

Nadège Corradini, MD

Each year, there are 2100 new cases of cancer in children and adolescents/young adults (AYA) in France. Due to a significant improvement in the effectiveness of therapies, the survival rate of all types of cancer combined after 5 years is 80-85%. This is leading to the emergence of new problems, which require an adaptation of the long-term care of these former patients. Nevertheless, although some medical complications have been widely described and are the subject of recommendations, many questions remain unanswered regarding the real long-term needs of patients and of their main caregivers.

The main objective of this study is to assess not only the specific supportive care needs of former onco-hematology patients treated before the age of 25 years, but also those of their parents up to 6 months after the end of the oncological follow-up, i.e. 3 to 5 years after the diagnosis.

The secondary objectives aim to:

1. Assess adherence to long-term follow-up medical consultation
2. Assess the early complications presented by the patients
3. Assess the quality of life and the anxiety-depression of former patients and their parents
4. Describe and evaluate the offer and use of the network of health professionals aware of the post-treatment issues; assess the referral to the network of health professionals aware of the post-treatment issues.

Depending on the objectives, the methodology used in this study is mixed, qualitative and quantitative. The study will be proposed systematically to all former patients of the hospital department diagnosed before the age of 25 years and at least 6 years of age at the time of inclusion as well as to their parents. A sample of 60 former pediatric patients (20 per age group) and 60-120 parents (ideally 40 per age group) is expected.

At the scientific level, this study will provide a better understanding of the cognitive and emotional processes involved in the long-term follow-up, in particular by identifying the supportive care needs of different participants (former patients and parents) and their experiences and quality of life during the long-term follow-up phase. At the individual level, this pilot study will enable the development of a multiprofessional structure, expert in cancer after-care from the end of the oncological follow-up.

Rational Each year, there are 2100 new cases of cancer in children and adolescents/young adults (AYA) in France. Due to a significant improvement in the effectiveness of therapies, the survival rate of all types of cancer combined after 5 years is 80-85%. This is leading to the emergence of new problems, which require an adaptation of the long-term care of these former patients. Many studies highlight that 60 to 65% of pediatric oncology patients will present medical and/or psychosocial complications in the 20 years following their oncological treatment, with a cumulative incidence of a serious adverse event of 40% 30 years after the cancer diagnosis. Nevertheless, although some medical complications have been widely described and are the subject of recommendations, many questions remain unanswered regarding the real long-term needs of patients and of their main caregivers, in this project their parents. It is therefore necessary to identify the risk factors by determining the expectations and the supportive care needs of patients and their caregivers in the long-term follow-up in order to intervene early and thus reduce the incidence of these later complications.

However, only 30 to 50% of former patients in pediatric oncology-hematology and their family attend a long-term follow-up medical consultation. We hypothesize that this lack of commitment is multifactorial (e.g. unmet supportive care needs, geographical distance from home, lack of information about the importance of long-term follow-up and follow-up structures nearby) and that a precise study of the needs expressed by former patients and their family should lead to an improved attendance at these consultations.

A better understanding of the supportive care needs of these patients and their families, as well as the brakes/obstacles or lers of their compliance with a long-term follow-up, is therefore essential to improve their quality of life, prevent or detect the sequela of therapies and reduce the risk of morbidity/mortality.

Objectives The main objective of this study is to assess not only the specific supportive care needs of former onco-hematology patients treated before the age of 25 years, but also those of their parents up to 6 months after the end of the oncological follow-up, i.e. 3 to 5 years after the diagnosis.

The secondary objectives aim to:

1. Assess adherence to long-term follow-up medical consultation
2. Assess the early complications presented by the patients
3. Assess the quality of life and the anxiety-depression of former patients and their parents
4. Describe and evaluate the offer and use of the network of health professionals aware of the post-treatment issues; assess the referral to the network of health professionals aware of the post-treatment issues.

Methodology Depending on the objectives, the methodology used in this study is mixed, qualitative and quantitative. The study will be proposed systematically to all former patients of the hospital department diagnosed before the age of 25 years and at least 6 years of age at the time of inclusion as well as to their parents. The experiences and the specific needs of each person (patients, mothers and fathers) will be assessed independently. Three independent groups will be formed based on the age of the patient when included in the study. For each group, the parents may or may not be paired with the patients. A sample of 60 former pediatric patients (20 per age group) and 60-120 parents (ideally 40 per age group) is expected.

Expected results At the scientific level, this study will provide a better understanding of the cognitive and emotional processes involved in the long-term follow-up, in particular by identifying the supportive care needs of different participants (former patients and parents) and their experiences and quality of life during the long-term follow-up phase. This first stage will be followed by more powerful studies on the modalities of following-up patients after cancer, in order to add to previously published research on the long-term medical and psychological side effects.

At the individual level, this pilot study will enable the development of a multiprofessional structure, expert in cancer after-care from the end of the oncological follow-up. This support could be initiated early and the link with the local network established quickly. It should reduce the experience of being abandoned presented by former patients and their families. At the family level, studying the needs expressed by parents could lead to a family psychological approach in order to restore the family links impacted by the disease.

At the organizational level, this study should serve as a basis for developing a structure that can carry out tertiary prevention, and thus reduce the costs attributable to long-term side effects (e.g. educational and professional absenteeism, use of treatments, private consultations or even hospitalization).

Supportive Care Needs of Former Child, AYA Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up

Supportive Care Needs of Former Child, Adolescent and Young Adult Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up

To identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up

Number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation

Clinical data : cardiac/renal/bones/digestive/hepatic/endocrine/dermatological/sexual/pulmonary/nutritional damages, pain, physical activity, addictology, tiredness, psychological follow-up

For child and adolescent patients (less than 15 years old at inclusion):

- Pediatric Quality of Life Inventory Cancer module

For patients over 15 years of age at the time of inclusion and parents:

- 36-Item Short Form Health Survey

For child and adolescent patients (less than 15 years old at inclusion):

* Screen for Child Anxiety Related Emotional Disorders Revised
* Children's Depression Inventory

For patients over 15 years of age at the time of inclusion and parents:

- Hospital Anxiety and Depression Scale

number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open Label Dose Escalation Study Of E7080	NCT00121719	Solid Tumor or ...	Lenvatinib	18 Years -	Eisai Inc.
Supportive Care Needs of Former Child, AYA Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up	NCT04711733	Solid Tumor or ...	Interview Self-report que... Medical consult...	6 Years - 31 Years	Centre Leon Berard
Supportive Care Needs of Former Child, AYA Cancer Patients, and of Their Parents: Evaluation During Long-term Follow-up	NCT04711733	Solid Tumor or ...	Interview Self-report que... Medical consult...	6 Years - 31 Years	Centre Leon Berard

Spots Global Cancer Trial Database for solid tumor or lymphoma