Radiation Dose Escalation in Locally Advanced Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Radiation: Dose Escalation Radiotherapy; Procedure: Delayed surgery

• Registration Number: NCT02603302
• Lead Sponsor: University of Brasilia

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.

Study Timeline

• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2016-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-11
• Last Update Posted: 2016-06-14
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Locally advanced rectal cancer	Dose Escalation Radiotherapy	RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV + Chemotherapy with 5-FU Surgery 8 weeks after the neoadjvuant treatment.
Locally advanced rectal cancer	Delayed surgery	RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV + Chemotherapy with 5-FU Surgery 8 weeks after the neoadjvuant treatment.

Primary Outcome Measures

Name	Time	Method
Pathologic complete response	Through study completion, an average of 2 years	Pathologic evaluation of the surgical specimen

Secondary Outcome Measures

Name	Time	Method
Disease free survival	2 years	Evaluation of disease free survival
Overall survival	2 years	Evaluation of overall survival

Trial Locations

Locations (1)

Brasilia Univeristy Hospital; 🇧🇷 Brasília, DF, Brazil