Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters (COLAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828227
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

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.

Condition or disease Intervention/treatment Phase
Elderly Patients Metastatic Colorectal Cancer Quality of Life Drug: OPTIMOX plus bevacizumab Drug: Capecitabine plus bevacizumab Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: "Candidate group" OPTIMOX plus bevacizumab (Arm A)

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 plus bevacizumab

Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles

  • 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-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w),
  • No 5-FU bolus.

then 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

Active Comparator: "Candidate group" - Capecitabine-bevacizumab (Arm B)

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
  • 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).

Active Comparator: "Non candidate group" - Capecitabine-bevacizumab

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
  • 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).




Primary Outcome Measures :
  1. Number of patients with improvement of 10 points on the assessment of the quality of life at 6 months in the "candidate group" [ Time Frame: At 6 months ]
    Improvement of 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)


Secondary Outcome Measures :
  1. Number of patients amenable to salvage surgery [ Time Frame: until 58 months ]
  2. Number of patients amenable to second-line therapy, [ Time Frame: until 58 months ]
  3. Number of patient amenable to locoregional therapy [ Time Frame: until 58 months ]
  4. Progression-free survival, [ Time Frame: until 58 months ]
    Progression-free survival 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.

  5. Overall survival [ Time Frame: Until 58 months ]
    Overall survival, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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,
  2. Neuropathy grade > 1,
  3. 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
  4. Uncontrolled hypercalcemia,
  5. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
  6. 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,
  7. History of arterial thrombotic and/or embolic event (e.g. myocardial infarction, stroke…) within 6 months prior to randomization,
  8. History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
  9. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
  10. 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,
  11. Concomitant administration of prophylactic phenytoin,
  12. Treatment with sorivudine or its chemically related analogues, such as brivudine,
  13. Patients with known allergy/hypersensitivity to any component of study drugs
  14. Concomitant unplanned anti-tumor treatment,
  15. Participation in another clinical trial with any investigational drug within 30 days prior to randomization,
  16. Other serious and uncontrolled non-malignant disease,
  17. Patient under guardianship, curatorship or under the protection of justice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828227


Contacts
Layout table for location contacts
Contact: Elisabeth CAROLA, MD 0140298500 Elisabeth.Carola@ghpso.fr
Contact: Marie-Line GARCIA LARNICOL, MD 0140298500 marie-line.garcia-larnicol@gercor.com.fr

Locations
Layout table for location information
France
CH Abbeville Not yet recruiting
Abbeville, France
Principal Investigator: Mathieu PAUWELS, MD         
CHU Amiens Hôpital sud Not yet recruiting
Amiens, France
Principal Investigator: Vincent HAUTEFEUILLE, MD         
Clinique de l'Europe Not yet recruiting
Amiens, France
Principal Investigator: Michel GOZY, MD         
CH Beauvais Not yet recruiting
Beauvais, France
Principal Investigator: Fayçal HOCINE, MD         
Hôpital Duchenne Recruiting
Boulogne-sur-Mer, France
Contact: Vincent BOURGEOIS, MD         
Principal Investigator: Vincent BOURGEOIS, MD         
Centre hospitalier de Cannes Recruiting
Cannes, France
Contact: Laurence SAUDES, MD         
Principal Investigator: Laurence SAUDES, MD         
CH Compiègne Noyon Not yet recruiting
Compiègne, France
Principal Investigator: Virginie SEBBAGH, MD         
UCOG Picardie Groupe Hospitalier Recruiting
Creil, France
Contact: Elisabeth CAROLA, MD         
Principal Investigator: Elisabeth CAROLA, MD         
CHU Henri Mondor Not yet recruiting
Créteil, France
Contact: Christophe TOURNIGAND, MD         
Principal Investigator: Christophe TOURNIGAND, MD         
Centre geroges François Leclerc Not yet recruiting
Dijon, France
Principal Investigator: Leïla BENGRINE, MD         
Institut Daniel Hollard Not yet recruiting
Grenoble, France
Contact: Christine REBISCHUNG, MD         
Principal Investigator: Cécile LEYRONNAS, MD         
Institut Hospitalier Franco-Britannique Not yet recruiting
Levallois-Perret, France
Contact: Honorine GERVAIS, MD         
Principal Investigator: Honorine GERVAIS, MD         
Hôpital Privé Jean Mermoz Recruiting
Lyon, France
Contact: Léa CLAVEL, MD         
Principal Investigator: Léa CLAVEL, MD         
Institut Paoli-Calmettes Not yet recruiting
Marseille, France
Principal Investigator: Pauline RIES-GUYE, MD         
CH Sud Ile de France Not yet recruiting
Melun, France
Principal Investigator: Hélène DALL'OSTO, MD         
CH Mont de Marsan Not yet recruiting
Mont-de-Marsan, France
Contact: Jérome DAUBA, MD         
Principal Investigator: Jérôme DAUBA, MD         
Centre Antoine Lacassagne Not yet recruiting
Nice, France
Contact: Eric FRANCOIS, MD         
Principal Investigator: Eric FRANCOIS, MD         
Hôpital des Diaconnesses Croix Saint Simon Recruiting
Paris, France
Contact: Catherine DELBALDO         
Principal Investigator: Catherine DELBALDO, MD         
Hôpital Saint Antoine Not yet recruiting
Paris, France
Contact: Daniel LOPEZ TRABADA ATAZ, Md         
Principal Investigator: Daniel LOPEZ TRABADA ATAZ, MD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France
Contact: Christophe LOUVET, MD         
Principal Investigator: Christophe LOUVET, MD         
CH Annecy Genevois Not yet recruiting
Pringy, France
Contact: Mathieu BACONNIER, MD         
Principal Investigator: Mathieu BACONNIER, MD         
CH Saint Malo Not yet recruiting
Saint-Malo, France
Principal Investigator: Anaïs BODERE, MD         
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group

Layout table for additonal information
Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT03828227     History of Changes
Other Study ID Numbers: COLAGE C18-01 PRODIGE 66
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action