locally advanced anal squamous cell carcinoma
Conditions
Brief summary
Disease-related event free survival (DFS) will be defined as the time between the date of randomization and the date of the first event (residual tumor at 6 months requiring an APR, progression, recurrence (local or metastatic) or death) or date of last news if the patient is alive without any event.
Detailed description
Overall survival (OS), Colostomy-free survival (CFS), toxicities and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Response rate will be evaluated by mRECIST criteria 1.1 and clinical examination, Quality of life scores, Pelvic reccurence rate at 2 years, Metastatic reccurence rate at 2 years
Interventions
DRUGCISPLATIN
DRUGFLUOROURACIL
DRUGMITOMYCIN
DRUGCAPECITABINE
DRUGDOCETAXEL
Sponsors
Fondation Franc.Cancerologie Digestive
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-related event free survival (DFS) will be defined as the time between the date of randomization and the date of the first event (residual tumor at 6 months requiring an APR, progression, recurrence (local or metastatic) or death) or date of last news if the patient is alive without any event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Colostomy-free survival (CFS), toxicities and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Response rate will be evaluated by mRECIST criteria 1.1 and clinical examination, Quality of life scores, Pelvic reccurence rate at 2 years, Metastatic reccurence rate at 2 years | — |
Countries
France
Outcome results
None listed