Elderly PatientsPhase 3COLAGENCT03828227
QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.
A Phase 3 study testing OPTIMOX-bevacizumab and Capecitabine plus bevacizumab in people with Elderly Patients and Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 22 sites in France.
Trial summary
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly Patients, Metastatic Colorectal Cancer, Quality of Life
- What is being tested?
- OPTIMOX-bevacizumab and Capecitabine plus bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 22 sitesFrance
- Study dates
- 14 Jun 2019to Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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,
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- 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).
Who cannot join
- 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,
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- 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,
- Other serious and uncontrolled non-malignant disease,
- Patient under guardianship, curatorship or under the protection of justice
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CH Abbeville
Abbeville
CHU Amiens Hôpital sud
Amiens
Clinique de l'Europe
Amiens
CH Beauvais
Beauvais
Hôpital Duchenne
Boulogne-sur-Mer
Centre hospitalier de Cannes
Cannes
CH Compiègne Noyon
Compiègne
UCOG Picardie Groupe Hospitalier
Creil
CHU Henri Mondor
Créteil
Centre geroges François Leclerc
Dijon
Institut Daniel Hollard
Grenoble
Institut Hospitalier Franco-Britannique
Levallois-Perret
Hôpital Privé Jean Mermoz
Lyon
Institut Paoli-Calmettes
Marseille
CH Sud Ile de France
Melun
CH Mont de Marsan
Mont-de-Marsan
Centre Antoine Lacassagne
Nice
Hôpital des Diaconnesses Croix Saint Simon
Paris
Hôpital Saint Antoine
Paris
Institut Mutualiste Montsouris
Paris
CH Annecy Genevois
Pringy
CH Saint Malo
St-Malo
About this study
Official title: Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
Read the detailed description
Treatment cohort will be determined based on three parameters:
- Serum albumin level at baseline,
- ECOG Performance Status,
- Mini GDS.
The "Candidate" group will be defined according to (all the following criteria must be fulfilled):
- Serum albumin level ≥ 30g/L,
- ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
The "Non-candidate" cohort group will be defined according to (at least one of those parameters is fulfilled):
- Serum albumin level < 30g/L.
- And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).
Patients in the "Candidate group" will be randomized to:
- OPTIMOX bevacizumab (arm A),
- Capecitabine + bevacizumab (arm B), in priority followed by FOLFOX-bevacizumab at first progression.
Patients in the "Non-candidate" group cohort
- Not randomized, follow-up patients receiving: capecitabine + bevacizumab
- Being tested
- OPTIMOX-bevacizumab, Capecitabine plus bevacizumab
- Keywords
- chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMOX-bevacizumabDrug
Also called Folinic acid (FA)-5-fluorouracil (5-FU)-oxaliplatin [OPTIMOX], Avastin
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
Capecitabine plus bevacizumabDrug
Also called capecitabine, Avastin
- 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).
| Study group | Role | What they receive |
|---|---|---|
| "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) Receives: 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: Receives: 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: Receives: Drug: Capecitabine plus bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months
Secondary outcomes (8)
Number of patients amenable to second-line therapy.
Proportion of patients amenable to second-line therapy.
Measured: until 58 months
Number of patient amenable to surgery and/or locoregional therapy.
Proportion of patients amenable to salvage surgery and/or locoregional therapy (e.g., radiofrequency ablation, stereotactic radiotherapy, …).
Measured: until 58 months
Progression-free survival (PFS)
PFS is defined as time from date of first dose of study treatment to date of first documented PD or death due to any cause determined by the Investigator assessment in accordance to RECIST 1.1. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.
Measured: until 58 months
Overall survival (OS)
OS defined as the time between the date of the first dose of study treatment and the death date. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Measured: Until 58 months
Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL
HRQoL: all other dimensions of the QLQC-30 and QLQELD-14 questionnaires, and longitudinal analyses of the QLQC-30 and QLQELD-14 elderly specific module integrating all measurement times.
Measured: Until 58 months
Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).
IADL as prognostic factor for overall survival (OS) and treatment toxicity.
Measured: Until 58 months
G8 score at baseline.
To determine G8 score at baseline and to correlate the candidate group and the non-candidate group according to G8 score.
Measured: until 58 months
Performance status geriatric (PSG) score.
External analysis of PSG score as predictive for treatment efficacy: PFS and OS.
Measured: until 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start14 Jun 2019
- Primary completion10 Nov 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth CAROLA, MD, Principal investigator, UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828227
- Sponsor's protocol ID
- COLAGE C18-01 PRODIGE 66
- Acronym
- COLAGE
- Status last verified
- Jul 2025
- First submitted
- 29 Jan 2019
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.
- ClinicalTrials.gov ID
- NCT03828227
- Acronym / sponsor ID
- COLAGE / COLAGE C18-01 PRODIGE 66
- Keywords
- chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
Detailed description
Treatment cohort will be determined based on three parameters:
- Serum albumin level at baseline,
- ECOG Performance Status,
- Mini GDS.
The "Candidate" group will be defined according to (all the following criteria must be fulfilled):
- Serum albumin level ≥ 30g/L,
- ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
The "Non-candidate" cohort group will be defined according to (at least one of those parameters is fulfilled):
- Serum albumin level < 30g/L.
- And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).
Patients in the "Candidate group" will be randomized to:
- OPTIMOX bevacizumab (arm A),
- Capecitabine + bevacizumab (arm B), in priority followed by FOLFOX-bevacizumab at first progression.
Patients in the "Non-candidate" group cohort
- Not randomized, follow-up patients receiving: capecitabine + bevacizumab
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Candidate group" OPTIMOX plus bevacizumab (Arm A) | Active comparator | Drug: OPTIMOX-bevacizumabPatients 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) |
| "Candidate group" - Capecitabine-bevacizumab (Arm B) | Active comparator | Drug: Capecitabine plus bevacizumabPatients 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: |
| "Non candidate group" - Capecitabine-bevacizumab | Active comparator | Drug: Capecitabine plus bevacizumabPatients 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: |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMOX-bevacizumabAlso: Folinic acid (FA)-5-fluorouracil (5-FU)-oxaliplatin [OPTIMOX], AvastinInduction 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 | Drug | "Candidate group" OPTIMOX plus bevacizumab (Arm A) |
| Capecitabine plus bevacizumabAlso: capecitabine, Avastin* 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). | Drug | "Candidate group" - Capecitabine-bevacizumab (Arm B), "Non candidate group" - Capecitabine-bevacizumab |
Primary outcome
Health-related quality of life (HRQoL) at 6 months in the "candidate group".
Time frame: At 6 months
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).
8 secondary outcomes
Number of patients amenable to second-line therapy.
Time frame: until 58 months
Number of patient amenable to surgery and/or locoregional therapy.
Time frame: until 58 months
Progression-free survival (PFS)
Time frame: until 58 months
Overall survival (OS)
Time frame: Until 58 months
Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL
Time frame: Until 58 months
Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).
Time frame: Until 58 months
G8 score at baseline.
Time frame: until 58 months
Performance status geriatric (PSG) score.
Time frame: until 58 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth CAROLA, MD principal investigator
UCOG Picardie Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPTIMOX-bevacizumab and Capecitabine plus bevacizumab in people with Elderly Patients and Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) at 6 months in the "candidate group". (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.