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Tracking Information | |||||
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First Received Date † | June 8, 2006 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | August 2003 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00335816 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer | ||||
Official Title † | Timing of Rectal Cancer Response to Chemoradiation | ||||
Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups according to time of study enrollment.
Patients then receive 5 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.
Patients then receive 3 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician. In all groups, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 1 month. PROJECTED ACCRUAL: A total of 248 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Colorectal Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 248 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00335816 | ||||
Responsible Party | Julio Garcia-Aguilar, UCSF Helen Diller Family Comprehensive Cancer Center | ||||
Secondary IDs †† | UCSF-03451, UCSF-H44287-23127-03, UMN-2003UC036 | ||||
Study Sponsor † | UCSF Helen Diller Family Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |