Radiation Dose Escalation in Locally Advanced Rectal Cancer

NCT02603302 | Unknown Phase 2

• 1 other identifier: 01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Rectal Cancer

Keywords

rectal cancer; radiotherapy; escalated dose; interval

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Pathologic evaluation of the surgical specimen

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Disease free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

Locally advanced rectal cancer

EXPERIMENTAL

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.

Radiation: Dose Escalation Radiotherapy; Procedure: Delayed surgery

Interventions

Dose Escalation Radiotherapy RADIATION

RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU

Locally advanced rectal cancer

Delayed surgery PROCEDURE

Surgery after 8 weeks with TME (total mesorectal excision)

Locally advanced rectal cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+

You may not qualify if:

• Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Brasilia Univeristy Hospital

Brasília, Federal District, 7676105, Brazil

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marcos Santos, MD PhD

  Brasília University

  STUDY CHAIR

Central Study Contacts

Marcos Santos, MD PhD

CONTACT

+ 55 61 83554308; marcosrxt@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 11, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)