Study on Non-Surgical Treatment Options for Rectal Cancer with Two Different Radiation Strategies
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials ID:NCT03051464
This clinical trial is exploring two different radiation treatment strategies for patients with rectal cancer, aiming to avoid surgery. The study involves 131 patients who will receive either standard chemoradiation with an external beam boost or standard chemoradiation followed by a brachytherapy boost.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare two radiation treatment strategies for rectal cancer that do not involve surgery. This is particularly important for older patients or those with other health issues. The trial will involve 145 patients with rectal cancer, who will be randomly assigned to one of two groups. One group will receive standard chemoradiation with an additional external beam radiation boost, while the other group will receive standard chemoradiation followed by a brachytherapy boost. The main goal is to see if these treatments can effectively preserve the rectum without the need for surgery.
Description
This study focuses on finding the best non-surgical treatment for rectal cancer, especially for older patients or those with other health conditions. The trial will compare two radiation strategies to see which is more effective in treating rectal cancer without surgery. Patients will be randomly assigned to one of two groups. Group A will receive standard chemoradiation therapy, which includes radiation and chemotherapy, followed by an extra dose of external beam radiation. Group B will receive the same standard chemoradiation therapy, but instead of the external beam boost, they will receive a brachytherapy boost, which is a type of internal radiation. The study aims to determine which method is better at preserving the rectum and achieving a complete clinical response. Patients with a high risk of cancer returning or with more advanced stages of the disease will not be included, as the study focuses on treating local disease only.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with rectal cancer, staged as T2-T3 using MRI or ultrasound.
- Cancer has not spread to lymph nodes (N0 stage).
- No signs of cancer spreading to other parts of the body.
- Tumor occupies less than half of the rectum's circumference.
- Tumor is less than 5 cm in size.
- Tumor is located less than 10 cm from the anal verge.
- Tumor penetration is less than 5 mm into surrounding fat.
- Tumor can be treated with brachytherapy.
- Rectum is accessible for colonoscopy.
- Suitable for brachytherapy and chemotherapy.
- Aged 18 years or older.
- Women of childbearing potential must use effective birth control.
- Must provide written informed consent.
Exclusion Criteria
- Previous radiation treatment to the pelvic area.
- Evidence of cancer spreading to distant parts of the body.
- Cancer extending into the anal canal.
- Tumors staged as T4.
- Tumors larger than 5 cm in length.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UT Southwestern Medical Center | 75390 | Dallas | Texas |
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