| Objective: |
Primary objective
To assess the efficacy of induction chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Secondary objectives
To compare induction chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on:
- 3-year Disease Free Survival and 3-year Overall Survival;
- Surgical morbidity and mortality (Dindo classification) at 30 days;
- Compliance to the neoadjuvant treatment ;
- Good tumor response;
- Quality of life at one year after surgery;
- To assess the toxicity of neoadjuvant treatment.
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| Aim: |
Primary endpoint : Proportion of curative surgery (R0 resection)
Secondary endpoints
- 3-year Disease Free and 3-year Overall Survival
- Surgical morbidity and mortality (Dindo classification) at 30 days after the surgery
- Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment
- Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature)
- Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery
- Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v4.0
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| Methods: |
This is a national, multicenter, open-label with blinded endpoint assessment, randomized, parallel-group phase III superiority clinical trial, comparing chemotherapy followed by pelvic reirradiation versus chemotherapy alone as neoadjuvant treatment before surgery in patients with local recurrent rectal cancer previously irradiated for the primary cancer. |
| Reason for International Trial: |
Feasibility |
