Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient.

Patients benefiting from the PROADAPT (interventional arm) program.

* A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month.
* Pre-operative physical training including strength, endurance and breathing exercises.
* A nutrition activity.
* An activity to educate patients (on nutrition, exercise).
* The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives.
* A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise.
* A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.

PROADAPT program

Claire FALANDRY, PR

Noual BAKRIN, MD

PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of published data (Figure).

It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.

This intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model.

This intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region.

PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research.

The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).

With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.

Surgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1.

In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.

PROADAPT-ovary/EWOC-2

Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)

• Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days

Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months

Clavien Dindo classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.

Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.

A complete therapeutic strategy consists of a complete cytoreductive surgery (CC0) 6 courses of chemotherapy at least in total, either in neo-adjuvant or in adjuvant setting, with at least 2 courses after surgery.

Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.

Overall survival is defined as the time from randomization to death from any cause

Hospices Civils de Lyon

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Docetaxel

Taxane

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.

Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.

Standard of Care: Docetaxel

Cycle 1: 600 mg/m\^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity.

Standard of Care: Cyclophosphamide

Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.

Function Assessment of Cancer Therapy (FACT) Surveys

Christine Walko, Pharm.D.

The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.

Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide

Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

The relationship between PK-guided docetaxel patient PK profiles and the Function Assessment of Cancer Therapy (FACT) Taxane and Breast Cancer scores will be described.

Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.

The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.

The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).

The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).

The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65. The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.

Saladax Biomedical, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.

Standard of Care + Surveys

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Recruiting ended early due to slow enrollment. Larger studies may help elucidate a more optimal AUC range for senior adults receiving docetaxel as part of the TC regimen for breast cancer to balance both toxicity and efficacy.

Christine M. Walko, Pharm.D., BCOP

AUC mg*hr/L: 2.5-3.7

AUC mg*hr/L: <2.5

All participants evaluable at time of analysis.

Rate of Achieving Targeted Area Under the Curve (AUC)

Participants with Grade 3 or 4 neutropenia

Participants with Febrile neutropenia

Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia

Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.

Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients

Association Between Scores - Instrumental Activities of Daily Living

Association Between Scores - Cumulative Illness Rating Scale for Geriatrics

Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores

Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.

Standard of Care: Docetaxel: Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.

Overall Study

Cancer patient population 70 years and older, eligible for screening.

Screening for geriatric issues to be referred to the Moffitt Cancer Center Oncogeriatric Information Team (OGIT).

Screening

Martine Extermann, M.D., Ph.D.

The main purpose of this study is to pilot a real time electronic consultation with an Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC). Investigators want to see for which type of patients this information is the most useful, and work out the practical ways of making this process work.

This is a multicenter study to test a real time consultation system using the Total Cancer CareTM database (TCC) cohort at the H. Lee Moffitt Cancer Center, Tampa, Florida, USA. The purpose is to make Moffitt's expertise available to private practice oncologists throughout Florida. An oncologist seeing an older patient with a difficult case could send key patient parameters to a senior adult expert at Moffitt. The TCC concierge would extract from the TCC database patients with similar characteristics. The oncogeriatric information team (OGIT) would review those cases and provide a summary report of treatments received and outcomes. The treating oncologist could then use that as an on-demand case series to help in the decision making. In order to pilot and build up the large scale intervention, several steps are necessary. The first step was a scenario testing with vignettes, which allowed tracing the most effective way of retrieving and formatting the information. The next step will be a pilot testing of the intervention in real time with one private practice.

Primary Aims:

To assess which format of expert-vetted database consultation and patient selection is the most useful to a private practice oncologist. We will test a model of approach and gain feedback on subjective utility and objective treatment modification profiles, in order to target a future study towards the stakeholders most likely to benefit. Impact of the consultation on treatment plan (per pre-post e-mails). Availability of similar patients in the TCC database.

Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database

Percentage of matching patients in Moffitt's Total Cancer Care (TCC) database. Percentage is expected to be greater than 80%.

Percentage of patients whose treatment plan was influenced/modified due to OGIT Consultation. Percentage is expected to be equal or greater than 20%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROADAPT-ovary/EWOC-2	NCT04284969	Ovarian Cancer Surgery	PROADAPT progra...	70 Years -	Hospices Civils de Lyon
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide	NCT02502864	Breast Cancer Breast Cancer F...	Standard of Car... Standard of Car... Function Assess...	65 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database	NCT02708381	Oncology Proble...	Screening	70 Years -	H. Lee Moffitt Cancer Center and Research Institute
PROADAPT-ovary/EWOC-2	NCT04284969	Ovarian Cancer Surgery	PROADAPT progra...	70 Years -	Hospices Civils de Lyon
Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database	NCT02708381	Oncology Proble...	Screening	70 Years -	H. Lee Moffitt Cancer Center and Research Institute

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