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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01285778 | Vectibix for the Treatment of Anal Cancer | PHASE2 | COMPLETED | 58 | — | — | Oct 1, 2010 | Mar 24, 2017 | May 16, 2018 | 20 | Spain |
To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and Panitumumab concurrently with radiation therapy as treatment for anal squamous cell carcinoma
| Arm | Type | Description |
|---|---|---|
| Panitumumab, mytomicin C, 5-FU, radiation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| panitumumab, mytomicin C, 5-FU, radiation | DRUG | Radiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order: * First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks * Then Mitomycin C, 10mg/m2 on days 1 and 29 * Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32 * Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy. |
Inclusion Criteria: * Man or woman ≥ 18 years * Competent to comprehend, sign, and date an IEC-approved informed consent form * Histologically or cytologically-confirmed anal canal SCC * T status 2-4 and any N status (pelvic or inguinal) radiologically defined by MRI * De novo diagnosis of anal can...