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Radiation Dose Escalation in Locally Advanced Rectal Cancer (RaDE)

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ClinicalTrials.gov Identifier: NCT02603302
Recruitment Status : Unknown
Verified June 2016 by Marcos Santos, University of Brasilia.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Marcos Santos, 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).

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: Dose Escalation Radiotherapy Procedure: Delayed surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced Rectal Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Locally advanced rectal cancer

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
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)




Primary Outcome Measures :
  1. Pathologic complete response [ Time Frame: Through study completion, an average of 2 years ]
    Pathologic evaluation of the surgical specimen


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 2 years ]
    Evaluation of disease free survival

  2. Overall survival [ Time Frame: 2 years ]
    Evaluation of overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603302


Contacts
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Contact: Marcos Santos, MD PhD + 55 61 83554308 marcosrxt@gmail.com

Locations
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Brazil
Brasilia Univeristy Hospital Recruiting
Brasília, DF, Brazil, 7676105
Contact: Marcos Santos, MD PHD    +55 61 83554308    marcosrxt@gmail.com   
Sponsors and Collaborators
University of Brasilia
Investigators
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Study Chair: Marcos Santos, MD PhD Brasília University
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Responsible Party: Marcos Santos, MD PhD, University of Brasilia
ClinicalTrials.gov Identifier: NCT02603302    
Other Study ID Numbers: 01
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may share data in requested by metanalists
Keywords provided by Marcos Santos, University of Brasilia:
rectal cancer
radiotherapy
escalated dose
interval
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases