A Phase 2 interventional study of Docetaxel, Cisplatin and 5-Fluorouracil in Anal Canal Carcinoma, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 2, Interventional, and Treatment
Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent.
Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen.
Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.
Epitopes-HPV02 study is a national multicenter open label phase II trial including 66 patients.
Patients will receive 6 cycles of DCF regimen (docetaxel 75 mg/m2 day, CDDP 75 mg/m2 and 5FU at 750 mg/m2/day for 5 days) every 3 weeks or 8 cycles of modified-DCF regimen (docetaxel 40 mg/m2 day, CDDP 40 mg/m2 day and 5-FU at 1200 mg/m2/day for 2 days) every 2 weeks, according to their clinical status.
CT scan will be planned at baseline, after 3 and after 6 cycles of DCF regimen (or after 4 and 8 cycles of modified-DCF regimen) and then every three months until disease progression or death. A Pet-scan will be performed before and after 6 cycles of DCF. Tumor assessment will be carried out according to RECIST V1.1 criteria.
This study is carried out by the University Hospital of Besançon and were approved by the independent Est-II French Committee for Protection of Persons (CPP) and by the French Health Products Safety Agency (ANSM). This study will be conducted in 17 clinical centers in France.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 70 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
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Exclusion Criteria:
docetaxel 75 mg/m2 day, Cisplatin75 mg/m2 and 5Fluorouracil at 750 mg/m2/day for 5 days
Drug: Docetaxel, Cisplatin and 5-Fluorouracil
Patients will receive 6 cycles of DCF regimen (docetaxel 75 mg/m2 day, cisplatin 75 mg/m2 and 5 Fluorouracil at 750 mg/m2/day for 5 days) every 3 weeks or 8 cycles of modified-DCF regimen (docetaxel 40 mg/m2 day, cisplatin 40 mg/m2 day and 5-Fluorouracil at 1200 mg/m2/day for 2 days) every 2 weeks, according to their clinical status.
Progression-free survival rate
Progression-free survival observed = the number of patients alive without progression at 12 months.
Time frame: 12 months after initiation of chemotherapy DCF.
Overall survival
time between the date of initiation of treatment and the date of death from any cause.
Time frame: date of death from any cause (within 3 years after the initiation of the treatment)
Progression free survival
time interval between the date of initiation of treatment and the date of first progression (local, remote \[extent of the disease by RECIST v1.1\] second cancer) or death from any cause.
Time frame: date of first progression of the disease (within 3 years after the initiation of the treatment)
response rate
response rate will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 by CT-scan
Time frame: 4 weeks after the end of DCF regimen
Tolerance of the DCF regimen ( Common Terminology Criteria for Adverse Events version 4.03)
description of toxicities and adverse events according to Common Terminology Criteria for Adverse Events version 4.03
Time frame: from the initiation of DCF regimen to 4 weeks after the end of DCF regimen
quality of life related to health
EORTC-QLQ-C30 \& time to QoL score deterioration
Time frame: from the inclusion to patient death or for maximum 3 years after end of treatment
HPV-specific T cell responses measured by ELISPOT assay before and after DCF treatment
HPV-specific T cell responses measured by ELISPOT assay
Time frame: at baseline (inclusion) and 4 weeks after the end of DCF regimen
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon