Radiation Dose Escalation in Locally Advanced Rectal Cancer (RaDE)

University of Brasilia

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Procedure: Delayed surgery; Radiation: Dose Escalation Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02603302

01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Locally advanced rectal cancer

Experimental group

Description:

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.

Treatment:

Procedure: Delayed surgery

Radiation: Dose Escalation Radiotherapy