Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Fatigue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

The control arm corresponds to usual care (without APA), including :

* Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol)
* Evaluation by the oncologist at the usual rate
* Assessment every 8 weeks (TAP scan + CA-19.9)
* Nutritional, psychological and pain management as recommended, according to the usual schedule.

The experimental arm corresponds to usual care, combined with a 16-week APA program.

The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner).

without APA program

Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

APA program

Pascal Hammel, MD

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.

The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.

200 randomized patients are required.

The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.

Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)

Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program

GERCOR - Multidisciplinary Oncology Cooperative Group

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Irinotecan

Leucovorin

Fluorouracil

Camptothecin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

GROUP A (Patients with unresectable advanced non-colorectal cancer ) - irinotecan + MM-398 dose escalation (3-18 patients)

Level 1 : initial DOUBLIRI dose 60/90 (0-3 patients)

* MM-398 : 60mg/m²
* Irinotecan (CPT-11) : 90mg/m²

Level 2: DOUBLIRI dose 80/90 (9 - 18 patients)

* MM-398 : 80mg/m²
* CPT-11: 90mg/m²

Level 3A: DOUBLIRI dose 60/120 (12-18 patients)

* MM-398 : 60mg/m²
* CPT-11: 120mg/m²

Level 3B: DOUBLIRI dose : 80/120 (12-18 patients)

* MM-398 : 80mg/m²
* CPT-11 : 120 mg/m²

GROUP B (Patients with unresectable metastatic colorectal cancer)- LV/5FU-bevacizumab+irinotecan+MM-398 dose Escalation (3-18 patients)

same level as group A + LV/5FU - bevacizumab regimen :

* Bevacizumab : 5mg/kg(day (d) 1)
* Leucovorin (LV) : 400mg/m² (d1)
* 5-fluorouracile infusion (5 FU) :2400mg/m² (d1,2)

unresectable Advanced non-colorectal cancer

MM-398

unresectable metastatic colorectal cancer

Leucovorin (LV)

5-fluorouracile (5-FU)

bevacizumab

Benoist Chibaudel, MD

MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect.

This study introduces a new concept of combining free and nanoliposomal drugs.

This is a dose-finding and therapeutic exploratory phase Ib multi-center, open label study of MM-398 plus irinotecan in two different settings:

* Group A : patients with unresectable advanced non-colorectal cancer who should receive only MM-398 and irinotecan
* Group B : patients with unresectable metastatic colorectal cancer who should receive MM-398 and irinotecan combined with leucovorin, 5-fluorouracil and bevacizumab.

These groups will be enrolling in parallel. Pharmacokinetic and biomarker sampling will also be performed.

There are three periods to this study :

Screening period (up to -28d): patients undergo screening assessments to determine the eligibility for the study

MM-398 treatment period (C1D1 until safety evaluation/progression): patients receive treatment every 2 weeks and undergo biopsies and other required assessments. The treatment period is divided into a maximum of 3 dose levels

Follow up period: patients will be followed-up 30 days after their last dose of MM-398 for final safety assessments, and every 2 months thereafter for overall survival follow-up

A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer

A Phase Ib Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer - DOUBLIRI

to determine the levels of MM-398/irinotecan, SN-38 and SN-38G

Merrimack Pharmaceuticals

Carcinoma

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

Nivolumab

Ipilimumab

Immune Checkpoint Inhibitors

Nivolumab administered IV followed by ipilimumab administered IV

Nicolas GIRARD, Pr

Thomas WALTER, Pr

Neuroendocrine tumors of the lung include the small cell carcinoma (SCLC), and large cell neuroendocrine carcinoma (LCNEC) and represent 20% of lung cancer. One of the only studies reported to date is reporting on a progression-free survival (PFS) and overall survival (OS) of 5.2 months and 7.7 months, respectively.

Poorly differentiated gastroentero-pancreatic neuroendocrine carcinomas (GEP-NEC) represent a small sub-group of digestive NENs, according to the studies, 7 to 21% of patients. However, their prognosis is more negative, with the 5-year survival at less than 20%.

Many Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab+/-ipilimumab versus standard chemotherapy in second-line treatment in metastatic solid tumors. Neuroendocrine tumors are considered as rare disease without therapeutic guidelines in this setting. The French academic oncology groups (IFCT, FFCD and GERCOR) have the opportunity to recruit a sufficient number of patients, in a reasonable period of time, to provide a proof-of-concept of the safety and efficacy of nivolumab+/-ipilimumab in this population.

Nivolumab +/- Ipilimumab in Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)

A GCO Trial Exploring the Efficacy and Safety of Nivolumab Monotherapy or Nivolumab Plus Ipilimumab in Pre-treated Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)

Number of patients with a best overall response of complete response (CR) or partial response (PR) assessed by investigators using validated criteria (i.e. RECIST 1.1) divided by the number of eligible patients.

Number of patients with a best overall response of complete response (CR) or partial response (PR) assessed by independent central review using validated criteria (i.e. RECIST 1.1) divided by the number of eligible patients.

Percentage of patients who will achieve complete response, partial response or stable disease

Time between the date of the best overall response of partial or complete response until the date of progressive disease or death due to any cause.

Time between the date of treatment start and the date of event defined as the first documented symptom deterioration

Time between the date of treatment start and the date of event defined as the first documented disease progression or death from any cause.

Time between the date of treatment start and the date of death from any cause.

Federation Francophone de Cancerologie Digestive

Intergroupe Francophone de Cancerologie Thoracique

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Aimery de Gramont, Pr

The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up of patients previously included in the AVANT trial from December 2004 to June 2007.

Clinical data of the AVANT trial will be updated. Neither additional examination nor administration of any treatment will be performed on the patients.

330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium, Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece, Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).

The AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer.

Adverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms.

A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.

Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median follow-up (expected to be reached around Q2 2016).

All analyses will be performed on an exploratory purpose only. An analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the AVANT trial including patients lost to follow up or died).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer	NCT02184663	Unresectable Lo... Metastatic Panc...	without APA pro... APA program	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group
A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer	NCT02640365	Unresectable Ad...	MM-398 Irinotecan Leucovorin (LV) 5-fluorouracile... bevacizumab MM-398	18 Years - 75 Years	GERCOR - Multidisciplinary Oncology Cooperative Group
Nivolumab +/- Ipilimumab in Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)	NCT03591731	Neuroendocrine ...	Nivolumab Ipilimumab	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma	NCT02228668	Colon Cancer Tr...		18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group

Spots Global Cancer Trial Database for gercor

Every month we try and update this database with for gercor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gercor

Every month we try and update this database with for gercor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gercor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.