QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.

NCT03828227 | Active Not Recruiting Phase 3

• 1 other identifier: COLAGE C18-01 PRODIGE 66
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 22

Brief Summary

A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.

Conditions

Elderly Patients; Metastatic Colorectal Cancer; Quality of Life

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQoL) at 6 months in the "candidate group".

  Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life).

  At 6 months

Secondary Outcomes (8)

• Number of patients amenable to second-line therapy.

  until 58 months

• Number of patient amenable to surgery and/or locoregional therapy.

  until 58 months

• Progression-free survival (PFS)

  until 58 months

• Overall survival (OS)

  Until 58 months

• Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL

  Until 58 months

Study Arms (3)

"Candidate group" OPTIMOX plus bevacizumab (Arm A)

ACTIVE COMPARATOR

Patients with : * Serum albumin level ≥ 30g/L, * ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression). Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)

Drug: OPTIMOX-bevacizumab

"Candidate group" - Capecitabine-bevacizumab (Arm B)

ACTIVE COMPARATOR

Patients with : * Serum albumin level ≥ 30g/L, * ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression). This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:

Drug: Capecitabine plus bevacizumab

"Non candidate group" - Capecitabine-bevacizumab

ACTIVE COMPARATOR

Patients with: * Serum albumin level \< 30g/L. * And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression). This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:

Drug: Capecitabine plus bevacizumab

Interventions

OPTIMOX-bevacizumab DRUG

Induction Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles (3 months) * Bevacizumab: 5 mg/kg IV (day 1, every 2 weeks \[q2w\]), * Folinic acid (FA): 400 mg/m² IV/2h (day 1, q2w), * Oxaliplatin: 85 mg/m² IV/2h (day 1, q2w), * 5-fluorouracil (5-FU) continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w), * No 5-FU bolus. then Maintenance Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity) * Bevacizumab: 5 mg/kg IV (day 1, q2w), * FA: 400 mg/m² IV/2h (day 1, q2w), * 5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w) * No 5-FU bolus

Also known as: Folinic acid (FA)-5-fluorouracil (5-FU)-oxaliplatin [OPTIMOX], Avastin

"Candidate group" OPTIMOX plus bevacizumab (Arm A)

Capecitabine plus bevacizumab DRUG

* Bevacizumab: 7.5 mg/kg intravenous infusion \[IV\] (day 1; q3w), * Capecitabine: 1000 mg/m² orally twice a day (day 1 through day 14, q3w).

Also known as: capecitabine, Avastin

"Candidate group" - Capecitabine-bevacizumab (Arm B); "Non candidate group" - Capecitabine-bevacizumab

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Signed and dated informed consent, and willing and able to comply with protocol requirements,
• Histologically proven colorectal adenocarcinoma,
• Confirmed metastatic disease,
• Patients with no detected dihydropyridine dehydrogenase (DPD) deficiency,
• No prior therapy for metastatic disease (in case of previous adjuvant chemotherapy, interval between the end of chemotherapy and relapse must be \> 6 months for fluoropyrimidine alone or \> 12 months for oxaliplatin-based chemotherapy,
• Duly documented unresectable metastatic disease i.e., not suitable for complete carcinological surgical resection,
• Age ≥ 75 years,
• ECOG PS 0-2,
• Hematological status: neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, and hemoglobin \> 9 g/dL,
• Adequate renal function: serum creatinine level \< 150 µmol/l, and creatinine clearance (Cockcroft and Gault or MDRD formula \> 30 mL/min),
• Adequate liver function: total bilirubin level \< 1.5 x upper normal limit (ULN), serum alkaline phosphatase (ALP) level \< 5 x ULN,
• Proteinuria \< 2+ (dipstick urinalysis) or ≤ 1g/24h,
• Regular follow-up feasible. The registered patient must be treated and followed at the participating center,
• Registration in France with the French National Health Care System (including dispositive PUMA (protection Universelle Maladie).

You may not qualify if:

• History or evidence upon physical examination of CNS metastasis (e.g. non- irradiated CNS metastasis, seizure not controlled with standard medical therapy), unless adequately treated,
• Neuropathy grade \> 1,
• Patient with known dihydropyridine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to a fluoropyrimidine-containing regimen, or in case of clinically significant active heart disease or myocardial infarction within 6 months or if patient treated with sorivudine or its clinically related analogues, such as brivudine
• Uncontrolled hypercalcemia,
• Uncontrolled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
• Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
• History of arterial thrombotic and/or embolic event (e.g. myocardial infarction, stroke…) within 6 months prior to randomization,
• History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
• Major surgery (open biopsy, surgical resection, wound revision or any other major surgery involving entry into body cavity) or significant traumatic injury within the last 28 days prior to randomization, and/or minor surgical procedure including placement of a vascular device within 2 days of first study treatment,
• Concomitant administration of prophylactic phenytoin,
• Treatment with sorivudine or its chemically related analogues, such as brivudine,
• Patients with known allergy/hypersensitivity to any component of study drugs
• Concomitant unplanned anti-tumor treatment,
• Participation in another clinical trial with any investigational drug within 30 days prior to randomization,

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (22)

CH Abbeville

Abbeville, France

Location

CHU Amiens Hôpital sud

Amiens, France

Location

Clinique de l'Europe

Amiens, France

Location

CH Beauvais

Beauvais, France

Location

Hôpital Duchenne

Boulogne-sur-Mer, France

Location

Centre hospitalier de Cannes

Cannes, France

Location

CH Compiègne Noyon

Compiègne, France

Location

UCOG Picardie Groupe Hospitalier

Creil, France

Location

CHU Henri Mondor

Créteil, France

Location

Centre geroges François Leclerc

Dijon, France

Location

Institut Daniel Hollard

Grenoble, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

CH Sud Ile de France

Melun, France

Location

CH Mont de Marsan

Mont-de-Marsan, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Hôpital des Diaconnesses Croix Saint Simon

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CH Annecy Genevois

Pringy, France

Location

CH Saint Malo

St-Malo, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Leucovorin; Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Elisabeth CAROLA, MD

  UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: June 14, 2019
• Primary Completion: November 10, 2023
• Study Completion: December 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)