ADAGE – PRODIGE 34

RANDOMISED PHASE III STUDY TO EVALUATE ADJUVANT CHEMOTHERAPY AFTER RESECTION OF A STAGE III COLON ADENOCARCINOMA, IN PATIENTS OF 70 YEARS AND OLDER.

Trial Status In preparation
Phase Phase III
Type of cancer A prospective, randomized, multicentric, phase III trial
Study design

The elderly population of the study will be divided into 2 groups according to the choice of the investigator, after a multidisciplinary evaluation involving geriatric parameters, with two
independent randomisations.

Objectives

Primary objectives: To compare the disease-free survival (DFS) of 2 therapeutic strategies in each group of patients aged 70 years or older over a period of 3 years, after resection of a stage III colon or upper rectal cancer.
Group 1 (able to receive bi-chemotherapy): A 7 % improvement in DFS is expected in the
oxaliplatin arm compared to the arm with 5FU or capecitabine.
Group 2 (unable to receive bi-chemotherapy): A 15 % improvement in DFS is expected in
the chemotherapy arm (5FU or capecitabine) compared to the arm with observation only.
Secundary objectives:
Dose intensity, tolerance (NCI CTC 4.0), time to recurrence, overall survival, time until
degradation of autonomy, time until deterioration of the quality of life.
Exploratory evaluation: research for prognostic factors derived from geriatric evaluation, evaluated according to the primary endpoint.

Inclusion Main criteria
  • Age ≥ 70 years
  • Patient deemed fit to receive chemotherapy by the multidisciplinary consultation meeting (MCM)
  • Detailed Lee score, faxed to the randomisation center
  • stage III adenocarcinoma of the colon or upper rectum
  • R0 Resection of the primary tumor
  • Possibility to start adjuvant chemotherapy within 12 weeks after surgery
  • Absence of previous chemotherapy for colon cancer
  • Geriatric Self-Questionnaire "Patient" completed, faxed to the randomisation center
  • Geriatric “team” questionnaire completed, faxed to the randomisation center
  • Effective contraception for male patients, throughout the treatment and at least 6 months after discontinuation of oxaliplatin
  • Signed informed consent (s)
Exclusion Main criteria
  • Other progressive malignant tumor (cancer not stabilized for less than 2 years)
  • Rectal cancer (located less than 15 cm from the anal margin by endoscopy or subperitoneal)
  • Neutrophils <2,000 / mm3 for group 1 and Neutrophils <1,500 / mm3 for group 2 and platelets <100,000 / mm3 or hemoglobin <9 g / dL
  • Neuropathy for Group 1 patients.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Patient with severe hepatic insufficiency.
  • Any contraindications to the drugs used in the study (refer to the updated versions of the SPCs of the products used, in Annex 10).
  • Not able to undergo the trial medical follow-up for geographical, social or psychological reasons.
Treatment schedule
  • Group 1: Patients deemed fit to receive dual chemotherapy by the multidisciplinary consultation meeting (MCM):
    • Arm A: fluoropyrimidine monotherapy (simplified LV5FU2 or capecitabine); 12 cycles of LV5FU2 or 8 cycles of capecitabine
    • Arm B: Simplified FOLFOX 4 (or XELOX); 12 cycles of FOLFOX or 8 cycles of XELOX
  • Group 2: Patients found to be unsuitable for bi-chemotherapy by the MCM.
    • Arm C: observation
    • Arm D: fluoropyrimidine monotherapy (simplified LV5FU2 or capecitabine); 12 cycles of LV5FU2 or 8 capecitabine

Choice of chemotherapy: The schedules using capecitabine or oxaliplatin are not
recommended if the creatinine clearance, calculated according to Cockcroft and Gault, is
<30 mL / min. In this case, the patient cannot be included in group 1; he can only be
included in group 2 if he receives 5FU infusion.
We recommend that patients with a history of heart disease will not be treated with
capecitabine. Attention: in case of use of this product in these patients, it will be necessary
to perform an ECG at Tmax, approximately 1.5h after the first capecitabine intake.

Study Period

Recruitment Start Date (FPI): 2018
Recruitment Finish Date (LPI): 2019
Follow-up Period End Date (LPO): 2024 (5 year follow-up)
End of trial is defined by the last patient last visit

Study Coordinators

Prof Marc Van den Eynde

Participating Groups

FFCD

Participating centres

UCL St-Luc
ULB Hôpital ERASME
CHU-UCL - Site Sainte Elisabeth
CHC St Joseph
CHU AMBROISE PARE
Onze Lieve Vrouw Ziekenhuis Aalst
CHU-UCL - Site Godinne

Protocol summary https://clinicaltrials.gov/ct2/show/NCT02355379?term=ADAGE&cond=Adenocarcinoma+of +the+Colon&rank=1
NCT number NCT02355379
EudraCT 2014-002517- 39
Interest to participate clinicaltrials@bgdo.org
More info clinicaltrials@bgdo.org