Radiation Dose Escalation in Locally Advanced Rectal Cancer (RaDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Dose Escalation Radiotherapy Procedure: Delayed surgery||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Pathologic complete response [ Time Frame: Through study completion, an average of 2 years ]Pathologic evaluation of the surgical specimen
- Disease free survival [ Time Frame: 2 years ]Evaluation of disease free survival
- Overall survival [ Time Frame: 2 years ]Evaluation of overall survival
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
|Contact: Marcos Santos, MD PhD||+ 55 61 email@example.com|
|Brasilia Univeristy Hospital||Recruiting|
|Brasília, DF, Brazil, 7676105|
|Contact: Marcos Santos, MD PHD +55 61 83554308 firstname.lastname@example.org|
|Study Chair:||Marcos Santos, MD PhD||Brasília University|