Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02701088 | Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life | PHASE2 | ACTIVE NOT_RECRUITING | 71 | — | — | Dec 1, 2015 | Dec 1, 2025 | Sep 22, 2025 | 8 | France |
The 3-month locoregional control rate after the end of IMRT by helical tomotherapy defined by the proportion of patients alive with no local disease progression 3 months after the end of radiotherapy
Tolerance profile: Proportion of patients with no significant (grade ≥3 according to NCI CTCAE v4.03) toxicities responsible for irradiation breaks
| Arm | Type | Description |
|---|---|---|
| Concomitant chemotherapy and radiotherapy | EXPERIMENTAL | Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions |
| Name | Type | Description |
|---|---|---|
| 5Fluorouracile and Mitomycin-C | DRUG | All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29). |
| Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy | RADIATION | SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes. |
Inclusion Criteria: * WHO performance status ≤ 2 * Age \> 18 years * Epidermoid anal canal carcinoma histologically proven, locally advanced with an indication of radiation of pelvic and inguinal nodes concomitantly to chemotherapy * The T corresponds to the larger dimension of tumor at the rectal ...