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Compares treatment options for Anal Cancer
Official title Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
ClinicalTrials.gov ID: NCT06207981
What this study is testing
What is induction chemotherapy (mDCF)?
induction chemotherapy (mDCF) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 score G8 \> 14 or favourable oncogeriatric assessment
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 according to NCIC-CTC 4.0
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 score G8 \> 14 or favourable oncogeriatric assessment
- Measurable tumor on MRI
- Able to receive chemotherapy and radiotherapy
- No major comorbidity that may preclude the delivery of treatment
- Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl
- Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min
- Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN
- WHO performance status \< 2
- Signature of informed consent
- 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...
- 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...
- Patient to be covered by a regimen of French Social Security system.
- 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 according to NCIC-CTC 4.0
- Contraindication for chemotherapy and/or radiotherapy
- Concomitant treatment with CYP3A4 inhibitors or inducers
- Symptomatic cardiac or coronary insufficiency
- Progressive active infection or any unbalanced progressive severe condition in the last 6 months
- No contraindication to MRI imaging
- 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
- breastfeeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Agen, France
- Aix-en-Provence, France
- Amiens, France
- Antony, France
- Argenteuil, France
- Arras, France
- Aurillac, France
- Auxerre, France
- Avignon, France
- Avranches, France
- Bayonne, France
- Beauvais, France
- Besançon, France
- Beuvry, France
- Bordeaux, France
- Boulogne-sur-Mer, France
- Brest, France
- Caen, France
- Cahors, France
- Caluire-et-Cuire, France
+ 60 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Agen, France; Aix-en-Provence, France; Amiens, France; Antony, France; Argenteuil, France; Arras, France and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.