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PRODIGE 34 - ADAGE: Randomised phase III study evaluating adjuvant chemotherapy after resection of stage III colon adenocarcinoma in patients aged 70 and older
EU CTIS ID: 2024-518741-21-00
What this study is testing
To compare the relapse-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients aged 70 and over after a stage III upper rectal or colon cancer resection.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 70
- Effective contraception for male patients throughout the treatment and at least 6 months after stopping the oxaliplatin treatment
- Informed consent(s) signed
- Patient deemed fit by the MCM to receive chemotherapy
- Lee’s score (Appendix 1) examined and faxed to the RMAC
- Stage III upper rectal or colon adenocarcinoma
You likely can't join if
- Another progressive malignant tumour (cancer not stabilised since less than 2 years)
- Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)
- PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL
- Neuropathy for the patients from group 1
- Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency
- Patient with severe liver insufficiency
See the full eligibility criteria
- Age ≥ 70
- Effective contraception for male patients throughout the treatment and at least 6 months after stopping the oxaliplatin treatment
- Informed consent(s) signed
- Patient deemed fit by the MCM to receive chemotherapy
- Lee’s score (Appendix 1) examined and faxed to the RMAC
- Stage III upper rectal or colon adenocarcinoma
- Resection R0 of the primary tumour
- Start of the adjuvant chemotherapy possible within 12 weeks after the surgery
- No prior chemotherapy for colon cancer
- Initial geriatric “patient” self-questionnaire completed and faxed to the RMAC (Appendix 2)
- Initial geriatric “team” questionnaire completed and faxed to the RMAC (Appendix 3)
- Another progressive malignant tumour (cancer not stabilised since less than 2 years)
- Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)
- PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL
- Neuropathy for the patients from group 1
- Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency
- Patient with severe liver insufficiency
- Any contra-indication to the medicinal products used in the study (refer to the updated versions of the SPCs of the products used, in Appendix 8)
- Impossibility to undergo the trial's medical follow-up for geographical, social, or psychological reasons
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.