NCT02603302

Radiation Dose Escalation in Locally Advanced Rectal Cancer

Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Dose Escalation Radiotherapy	RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
PROCEDURE	Delayed surgery	Surgery after 8 weeks with TME (total mesorectal excision)

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-11-11
• Last updated: 2016-06-14

Locations

1 site across 1 country: Brazil