Study on Radiation and Chemotherapy, With or Without Additional Chemotherapy, Followed by Surgery for Stage II or III Rectal Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT00335816
This clinical trial is exploring whether combining radiation therapy with chemotherapy, and possibly additional chemotherapy, before surgery can help shrink tumors in patients with Stage II or III rectal cancer, making surgery more effective.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if using radiation therapy along with chemotherapy drugs like fluorouracil, oxaliplatin, and leucovorin before surgery can help reduce the size of rectal cancer tumors. This approach may make it easier to remove the cancer during surgery and potentially spare more healthy tissue. The trial will also look at whether adding more chemotherapy after radiation can improve outcomes.
Description
The main goals of this study are to see how well the combination of radiation and chemotherapy works in eliminating cancer cells in patients with Stage II or III rectal cancer. Researchers will also examine how the timing between chemotherapy and surgery affects the treatment's success and any surgical challenges or complications that may arise.
Participants will be divided into four groups:
- Group I: Patients will receive radiation and chemotherapy, followed by surgery.
- Group II: After radiation and chemotherapy, patients will receive additional chemotherapy for two cycles before surgery.
- Group III: Similar to Group II, but with four cycles of additional chemotherapy before surgery.
- Group IV: Similar to Group II, but with six cycles of additional chemotherapy before surgery.
All participants will continue treatment unless the cancer progresses or side effects become too severe. After completing the study treatment, patients will be monitored for five years to track their health and any recurrence of cancer.
Eligibility Criteria
Inclusion Criteria
- Must be in good overall health with an ECOG status of 0 or 1.
- Must have a confirmed diagnosis of invasive rectal cancer within 12 cm of the anal verge.
- Cancer must be Stage II or III, as confirmed by specific imaging tests.
- Must not have metastatic disease or other primary cancers.
- Must not have a history of certain genetic conditions or inflammatory bowel disease.
- Must not have had prior radiation to the pelvis or significant heart disease.
- Must not have uncontrolled seizures or significant mental health issues.
- Must not be allergic to the study drugs.
- Must have adequate blood cell counts and organ function.
- Must agree to use effective birth control during treatment.
- Must provide written consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Care Center at John Muir Health - Concord Campus | 94524-4110 | Concord | California |
| City of Hope Medical Center | 91010-3000 | Duarte | California |
| St. Joseph Hospital Regional Cancer Center - Orange | 92868-3849 | Orange | California |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | 92868 | Orange | California |
| UCSF Helen Diller Family Comprehensive Cancer Center | 94115 | San Francisco | California |
| Washington Cancer Institute at Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | 33612-9497 | Tampa | Florida |
| University of Chicago Cancer Research Center | 60637-1470 | Chicago | Illinois |
| Masonic Cancer Center at University of Minnesota | 55455 | Minneapolis | Minnesota |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | 63110 | St Louis | Missouri |
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