New treatment approach for locally advanced anal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Argenteuil - Ch
  Argenteuil, France Recruiting
• AUXERRE CH GHT Unyon
  Auxerre, France Recruiting
• Avignon Icap
  Avignon, France Recruiting
• Avranches - Hopital Prive de La Baie
  Avranches, France Recruiting
• Besancon Chu
  Besançon, France Recruiting
• Bordeaux - Privé - Tivoli
  Bordeaux, France Recruiting

+64 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Veronique Vendrely, Md-pHD — University Hospital, Bordeaux
• Study coordinator: Veronique Vendrely, Md-pHD
• Email: prodige85.kanalrad@ffcd.fr
• Phone: +33 380393483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.