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New treatment approach for locally advanced anal cancer

PRODIGE 85- 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)

Phase 3 Interventional Federation Francophone de Cancerologie Digestive · NCT06207981

This study is testing a new treatment plan that combines chemotherapy and radiation to see if it can help people with advanced anal cancer live longer and have fewer relapses.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment310 (estimated)
Ages18 Years and up
SexAll
SponsorFederation Francophone de Cancerologie Digestive Academic / other
Drugs / interventionschemotherapy, radiation
Locations114 sites (Agen and 113 other locations)
Trial IDNCT06207981 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a new treatment strategy for patients with locally advanced anal squamous cell carcinoma (SCCA) by combining induction chemotherapy using a modified DCF protocol with subsequent chemoradiotherapy. The aim is to improve treatment efficacy for patients with T3-T4 or N1 stage tumors, which typically have poor prognoses. Participants will receive a regimen of chemotherapy followed by radiotherapy, with the goal of reducing relapse rates and improving overall survival. The study is designed for patients who meet specific eligibility criteria, including age and health status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically proven locally advanced anal squamous cell carcinoma without metastases.

Not a fit: Patients with major comorbidities that preclude treatment or those with metastatic disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce relapse in patients with locally advanced anal cancer.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Anal Squamous cell carcinoma histologically proven
2. Locally advanced tumors without metastases

   * Stage T3 or T4
   * Stage N1 (a, b or c) - any T (T1 to T4)
3. Age ≥18 and ≤ 75 or \> 75 in case of score G8 \> 14 or favourable oncogeriatric assessment
4. Measurable tumor on MRI
5. Able to receive chemotherapy and radiotherapy
6. No major comorbidity that may preclude the delivery of treatment
7. Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl
8. Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min
9. Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN
10. WHO performance status \< 2
11. Signature of informed consent
12. A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a "urine pregnancy test", it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)
13. Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)
14. Patient to be covered by a regimen of French Social Security system.

Exclusion Criteria:

1. Presence of metastases
2. Stage T1N0 or T2N0
3. History of pelvic radiotherapy
4. Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
5. Positive HIV serology with CD4 \< 400 / mm3
6. Presence of neuropathy \> grade 2 according to NCIC-CTC 4.0
7. Contraindication for chemotherapy and/or radiotherapy
8. Concomitant treatment with CYP3A4 inhibitors or inducers
9. Symptomatic cardiac or coronary insufficiency
10. Progressive active infection or any unbalanced progressive severe condition in the last 6 months
11. No contraindication to MRI imaging
12. Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma or any other carcinoma in situ considered as cured
13. breastfeeding woman.
14. Persons deprived of liberty or under guardianship or incapable of giving consent
15. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
16. Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine

Where this trial is running

Agen and 113 other locations

+64 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Anal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.