- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060007
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the rectum
- Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
- Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
- Karnofsky Performance Status at >60
- Laboratory criteria:
- Absolute neutrophil count >= 1.5 K
- Platelets >= 100 K
- Total Bilirubin <= 2.0;
- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- Creatinine < 2.0
- Hemoglobin >= 8.0
- Informed consent signed
- Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
- Estimated longevity at least 12 months
- Patients with distant metastatic disease will be eligible if they satisfy all other conditions
Exclusion Criteria:
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
- Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
- Prior chemotherapy for colorectal cancer.
- Grade >= 2 peripheral neuropathy
- Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of T Stage Downstaging
Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
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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).
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Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
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Preoperative Gastrointestinal Morbidity
Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
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As measured by participants who experience grade 3 or higher gastrointestinal morbidity
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Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
|
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Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
Time Frame: 1 year (completion of all treatment)
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1 year (completion of all treatment)
|
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Local Control
Time Frame: 30 months
|
|
30 months
|
Rate of Overall Control
Time Frame: 1 year
|
1 year
|
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Rate of Locoregional Control
Time Frame: 1 year
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1 year
|
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Freedom From Disease Relapse
Time Frame: 30 months
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Kaplan-Meier projections.
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30 months
|
Determine Quality of Anorectal Function
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- 09-0696 / 201106272
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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