Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT01060007|
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : February 10, 2015
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Radiation: External beam radiation Drug: Oxaliplatin Drug: Leucovorin Drug: 5-FU Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||September 2014|
Experimental: Neoadjuvant radiation followed by FOLFOX
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.
FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).
If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
Radiation: External beam radiation
Other Name: EloxatinDrug: Leucovorin Drug: 5-FU
Other Names:Drug: Capecitabine
Other Name: Xeloda
- Rate of T Stage Downstaging [ Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) ]T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
- Preoperative Gastrointestinal Morbidity [ Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) ]As measured by participants who experience grade 3 or higher gastrointestinal morbidity
- Incidence of Any Late Grade 3 or Higher Morbidity [ Time Frame: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks) ]
- Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity [ Time Frame: 1 year (completion of all treatment) ]
- Local Control [ Time Frame: 30 months ]
- Kaplan-Meier projections
- Local control = control of primary tumor
- Rate of Overall Control [ Time Frame: 1 year ]
- Rate of Locoregional Control [ Time Frame: 1 year ]
- Freedom From Disease Relapse [ Time Frame: 30 months ]Kaplan-Meier projections.
- Determine Quality of Anorectal Function [ Time Frame: Up to 1 year ]Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060007
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Parag Parikh, M.D.||Washington University School of Medicine|