Condition: Anal Cancer · Sponsor: Federation Francophone de Cancerologie Digestive
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. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer. the efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerabilit…
This description comes directly from the study's public registry record.
Veronique Vendrely, Md-pHD · +33 380393483 · prodige85.kanalrad@ffcd.fr
Jérémie BEZ, MS · +33 380393483 · prodige85.kanalrad@ffcd.fr
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| AGEN-Cromg | Agen, France | Not Yet Recruiting |
| Clinique Calabet | Agen, France | Not Yet Recruiting |
| AIX EN PROVENCE CH Pays d'Aix | Aix-en-Provence, France | Not Yet Recruiting |
| Amiens - Clinique de L'Europe | Amiens, France | Not Yet Recruiting |
| ANTONY Hôpital Privé | Antony, France | Not Yet Recruiting |
| Argenteuil - Ch | Argenteuil, France | Recruiting |
| ARRAS Les Bonnettes | Arras, France | Not Yet Recruiting |
| ARRAS Marie Curie | Arras, France | Not Yet Recruiting |
| AURILLAC-Henri Mondor | Aurillac, France | Not Yet Recruiting |
| Centre Medico Chirurgical | Aurillac, France | Not Yet Recruiting |
| AUXERRE CH GHT Unyon | Auxerre, France | Recruiting |
| Avignon Icap | Avignon, France | Recruiting |
+ 102 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06207981