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PRODIGE 85 (FFCD 1804) – KANALRAD Prospective randomized phase III study evaluating induction chemotherapy (modified DCF 4 cycles) followed by chemoradiotherapy compared to standard chemoradiotherapy for locally advanced anal squamous cell carcinoma (T3-4 or N1a, b or c)
EU CTIS ID: 2023-505972-32-00
What this study is testing
Efficacy of induction chemotherapy by mDCF (4 cycles) followed by standard CRT versus standard CRT alone by comparing disease related event-free survival at 2 years.
- Therapeutic confirmatory (Phase III)
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
- Anal Squamous cell carcinoma histologically proven
- Locally advanced tumors without metastases (Stage T3 or T4 / Stage N1 (a, b or c) - any T (T1 to T4) )
- Age ≥18 and ≤ 75 or > 75 in case of favourable oncodage G8 score or oncogeriatric assessment
- Measurable tumor on MRI
- Able to receive chemotherapy and radiotherapy
- No major comorbidity that may preclude the delivery of treatment
You likely can't join if
- Presence of metastases
- Stage T1N0 or T2N0
- History of pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Positive HIV serology with CD4 < 400 / mm3
- Presence of neuropathy > grade 2
See the full eligibility criteria
- Anal Squamous cell carcinoma histologically proven
- Locally advanced tumors without metastases (Stage T3 or T4 / Stage N1 (a, b or c) - any T (T1 to T4) )
- Age ≥18 and ≤ 75 or > 75 in case of favourable oncodage G8 score or oncogeriatric assessment
- Measurable tumor on MRI
- Able to receive chemotherapy and radiotherapy
- No major comorbidity that may preclude the delivery of treatment
- WHO performance status < 2
- Presence of metastases
- Stage T1N0 or T2N0
- History of pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Positive HIV serology with CD4 < 400 / mm3
- Presence of neuropathy > grade 2
- Concomitant treatment with CYP3A4 inhibitors or inducers
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, 18-64 years. The study team makes the final eligibility decision.
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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.