PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Colorectal Cancer
In brief
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Key facts
- Study ID
- NCT01515787
- Run by
- Alliance for Clinical Trials in Oncology
- People needed
- 1194
- Starts
- 2012-06-12
- Expected to finish
- 2024-06-30
- Last updated by the study team
- 2024-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Southern Cancer Center PC-Daphne — Daphne, Alabama, United States
- Southern Cancer Center PC-Mobile — Mobile, Alabama, United States
- Southern Cancer Center PC-Providence — Mobile, Alabama, United States
- Southern Cancer Center PC-Springhill — Mobile, Alabama, United States
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States
- Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
- Alaska Regional Hospital — Anchorage, Alaska, United States
- Alaska Women's Cancer Care — Anchorage, Alaska, United States
- Anchorage Oncology Centre — Anchorage, Alaska, United States
- Katmai Oncology Group — Anchorage, Alaska, United States
- Providence Alaska Medical Center — Anchorage, Alaska, United States
- Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
- University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
- The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
- Yuma Cancer Center — Yuma, Arizona, United States
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
- Highlands Oncology Group-Rogers — Rogers, Arkansas, United States
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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