Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA

Launched by FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE · Jan 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced anal cancer, specifically squamous cell carcinoma. The trial compares two methods: one that uses a combination of chemotherapy (called modified DCF) followed by standard chemoradiotherapy (a mix of radiation and chemotherapy), and the standard chemoradiotherapy alone. The goal is to see if the new method can help patients live longer without their cancer coming back.

To be eligible for this trial, participants must be at least 18 years old with advanced anal cancer that has not spread to other parts of the body. Key criteria include being healthy enough to receive chemotherapy and radiation, and having measurable tumors seen on MRI scans. Participants can expect to undergo a series of treatments followed by regular check-ups for up to three years to monitor their health and response to the treatment. This trial is open to both men and women and aims to provide valuable insights into improving outcomes for patients facing this challenging disease.

Gender

ALL

Eligibility 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