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Type(s) of Cancer
Colorectal
Study Phase
Phase 2Phase 3
Study Completion Date
2022-12-31
NCT01515787Uploaded 08-24-2024
Access via NCI by Request
PDS UID: nci-data-550
A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)
Provider Information
Provider Data DescriptionDataset NCT01515787-D1-Dataset.csv (final) is one of 2 datasets associated with PubMed ID 37272534. This dataset contains demographic and outcomes data presented in the primary manuscript and Supplementary Tables 3A, 3B, and 4 and the Supplementary Figure.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsColorectal Cancer
Intervention TypeDrug: FOLFOX (chemotherapy)
Other: 5 FUCMT (chemoradiation)
Procedure: surgery
Procedure: magnetic resonance imaging or endorectal ultrasound
Drug(s)Drug: FOLFOX (chemotherapy)
Total Enrolled1194
RandomizationRandomized
Blinding MethodNone
Arms InterventionGroup 1 - Experimental
Group 2 - Active Comparator
Secondary IDCDR0000715321
PubMed (PMID)30688523
Collaborator(s)National Cancer Institute (NCI)
Canadian Cancer Trials Group
Region(s)United States
Canada
Israel
Switzerland
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01515787-D1
Data DictionaryNCT01515787-D1-Data-Dictionary.pdf
DATANCT01515787-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT01515787-D2
Data DictionaryNCT01515787-D2-Data-Dictionary.pdf
DATANCT01515787-D2-Dataset.csv
OTHERREADME.pdf
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