Rectal Cancer
Conditions
Keywords
rectal cancer, radiotherapy, escalated dose, interval
Brief summary
This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).
Detailed description
Introduction: Rectal cancer is a highly prevalent disease all over the world. In Brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants. Goals: The aim of this study is to evaluate the pathologic complete response (pCR) of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant radiochemotherapy (RCT) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy. Procedures: Neoadjuvant chemoradiotherapy with radiation dose escalation associated with radiosensitizing therapy and surgery with a total mesorectal excision (TME), 8 weeks after completing neoadjuvant treatment.
Interventions
RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
Surgery after 8 weeks with TME (total mesorectal excision)
Sponsors
Study design
Eligibility
Inclusion criteria
* Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+
Exclusion criteria
* Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response | Through study completion, an average of 2 years | Pathologic evaluation of the surgical specimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 2 years | Evaluation of disease free survival |
| Overall survival | 2 years | Evaluation of overall survival |
Countries
Brazil