Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy and FOLFOX Chemotherapy for Rectal Cancer (HDRBT)
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|ClinicalTrials.gov Identifier: NCT01659424|
Recruitment Status : Withdrawn (No participants were enrolled)
First Posted : August 7, 2012
Last Update Posted : December 18, 2014
Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs. Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be given three chemotherapy medications both before and after surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid).
The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy and external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) FOLFOX Chemotherapy for Stage II/III Rectal Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
This is a single arm study.
Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT)
Combining pre-operative FOLFOX chemotherapy with HDR-ERBT (Radiation therapy) followed by surgery then additional FOLFOX chemotherapy to decrease the risk of distant metastasis and to maintain excellent locoregional control with decreased morbidity.
- Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) Improve Compliance [ Time Frame: five years ]Investigator propose combining pre-operative FOLFOX chemotherapy with high dose rate endorectal brachytherapy followed by surgery and then additional FOLFOX chemotherapy to further improve compliance.
- Locoregional failure [ Time Frame: 5 years ]
- Distant Metastasis [ Time Frame: 5 years ]
- Toxicity [ Time Frame: 1 year ]Number of participant with Bladder, Bowel, Sexual function and Bone Marrow Toxicity.
- 4) Quality of Life [ Time Frame: 5 year ]
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): NCT01659424
|United States, New York|
|Beth Isael Medical Center|
|New York, New York, United States, 10003|
|St-Lukes Roosevelt Hospital Medical Center|
|New York, New York, United States, 10018|
|Principal Investigator:||Kenneth Hu, MD||Beth Israel Medical Center NY|