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View Clinical Trial (Medical Research Study)
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Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer - NCT00335816-92868A (Clinical Trial 145146)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy145146.aspx
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| City: |
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Orange |
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State:
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CA |
| Zip Code: |
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92868 |
| Conditions: |
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Colorectal Cancer |
| Purpose: |
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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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| Study summary: |
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OBJECTIVES:
- Determine the rate of pathologic complete response (i.e., no evidence of residual tumor
in the resected specimen) in patients with stage II or III rectal cancer treated with
neoadjuvant chemoradiotherapy comprising radiotherapy and fluorouracil with or without
combination chemotherapy comprising oxaliplatin, leucovorin calcium, and fluorouracil
followed by surgical resection.
- Determine the effect of different chemoradiation-to-surgery intervals on the rate of
pathologic complete response, surgical difficulty, and postoperative complications in
these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups
according to time of study enrollment.
- Group 1: Patients undergo chemoradiotherapy comprising radiotherapy once daily 5 days a
week for 5 weeks and fluorouracil (5-FU) IV continuously over 24 hours 7 days a week
for 5 weeks (weeks 1-5). Patients undergo surgical resection of the rectum in week 12.
Patients then receive 9 courses of FOLFOX-6 chemotherapy comprising oxaliplatin,
leucovorin calcium, and 5-FU or other chemotherapy off study as directed by the
physician.
- Group 2: Patients undergo chemoradiotherapy as in group 1. Beginning in week 10,
patients receive FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and
leucovorin calcium IV over 2 hours followed by bolus 5-FU on day 1 and 5-FU IV
continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 2
courses. Patients undergo surgical resection of the rectum in week 16. Patients then
receive 7 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study
as directed by the physician.
- Group 3: Patients undergo chemoradiotherapy as in group 1. Beginning in week 10,
patients receive FOLFOX-6 chemotherapy comprising oxaliplatin, leucovorin calcium, and
5-FU as in group 2. Treatment repeats every 14 days for 4 courses. Patients undergo
surgical resection of the rectum in week 20. Patients then receive 5 additional courses
of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.
- Group 4: Patients undergo chemoradiotherapy as in group 1. Beginning in week 10,
patients receive FOLFOX-6 chemotherapy comprising oxaliplatin, leucovorin calcium, and
5-FU as in group 2. Treatment repeats every 14 days for 6 courses. Patients undergo
surgical resection of the rectum in week 24. 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. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the rectum
- Distal border of the tumor must be within 12 cm from the anal verge as measured
on rigid proctoscopic exam
- Stage II (T3, N0) or Stage III (any T, N1) disease confirmed by endorectal
ultrasound (ERUS) or MRI
- Patients with a high-grade obstruction that impedes the ERUS exam are
eligible if staged by MRI
- Patients with synchronous or metachronous colorectal cancer are eligible provided
they are treated for rectal cancer in accordance with this protocol
- Hereditary non-polyposis colorectal cancer allowed provided the patient meets all
study eligibility criteria
- No metastatic disease or other primaries
- No locally recurrent rectal cancer
- No history of familial adenomatous polyposis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- No history of any of the following significant cardiac diseases:
- New York Heart Association class III-IV congestive heart failure
- Symptomatic coronary artery disease
- Uncontrolled arrhythmia
- Myocardial infarction within the past 6 months
- No history of inflammatory bowel disease
- No history of uncontrolled seizures or clinically significant CNS disorders
- No history of psychiatric conditions or diminished capacity that would preclude
giving informed consent or complying with the study
- No allergy and/or hypersensitivity to fluorouracil, leucovorin calcium, and/or
oxaliplatin
- No history of difficulty or inability to take or absorb oral medications
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 9.5 g/dL
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 3mg/dL
- AST and ALT ≤ 2.0 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.0 times ULN
- Creatinine ≤ 1.5 times ULN
- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma
in situ of the cervix
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the pelvis
- No other concurrent investigational drugs
- No other concurrent anticancer therapy |
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| Study is available at: |
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, CA 92868
United States
Primary Contact:
Clinical Trials Office - Chao Family Comprehensive Cancer Cent
Email: ucstudy@uci.edu
Phone: 877-UC-STUDY |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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