KANALRADPRODIGE 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)
induction chemotherapy (mDCF)
+ Concomitant chemotherapy (Capecitabin + Mitomycin-C)
+ radiotherapy
Anus Diseases+10
+ Anus Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: February 26, 2024
Actual date on which the first participant was enrolled.This clinical trial focuses on improving treatment for patients with locally advanced anal squamous cell carcinoma, a type of cancer linked to the human papillomavirus (HPV). The standard treatment currently combines chemotherapy and radiotherapy, which works well for early-stage tumors but is less effective for more advanced stages. The trial aims to test a new strategy by adding a combination of three chemotherapy drugs—docetaxel, cisplatin, and 5FU, known as mDCF—before the usual treatment, to see if this approach can lead to better outcomes for patients. The study targets adults over 18, including those over 75 with a favorable health evaluation and patients with well-managed HIV. During the trial, participants will receive either the standard chemoradiotherapy or the new treatment method, which starts with four sessions of the mDCF chemotherapy given every two weeks, followed by the usual chemoradiotherapy. The effectiveness of these treatments will be compared by looking at the patients' survival without the disease worsening over two years, as well as their overall survival, the need for colostomy, how well they tolerate the treatment, their response to the treatment, and their quality of life. After the treatment, patients will have regular follow-ups involving clinical exams and imaging to monitor their condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.310 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 114 locations
Avranches - Hopital Prive de La Baie
Avranches, FranceBesancon Chu
Besançon, FranceBordeaux - Privé - Tivoli
Bordeaux, France