Radiation Dose Escalation in Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— RaDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02603302
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 2
• First received: November 6, 2015
• Last updated: June 11, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: University of Brasilia
• Contact: Marcos Santos, MD PhD
• Phone: + 55 61 83554308
• Email: marcosrxt[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Brazil	Brasilia Univeristy Hospital	Brasília	DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response	Pathologic evaluation of the surgical specimen	Through study completion, an average of 2 years	Yes
Secondary	Disease free survival	Evaluation of disease free survival	2 years	Yes
Secondary	Overall survival	Evaluation of overall survival	2 years	Yes