Status:
UNKNOWN
A Study for Short Preoperative Chemoradiotherapy for Resectable Rectal Carcinoma
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Chemoradiotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Intensity modulated radiotherapy (IMRT)-based radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Investiga...
Detailed Description
Preoperative chemoradiotherapy has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative applicati...
Eligibility Criteria
Inclusion
- Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)
- Located up to 15 cm from the anal verge with no extension of malignant disease into the anal canal
- Stage IIIB-IIIC disease (T3-T4, N0-2, M0)(i.e., without evidence of distant metastases) tumor as determined by the following assessments:Colonoscopy and biopsy within the past 8 weeks; History/physical examination (including medication history screen for contraindications) within the past 8 weeks; Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or PET-CT (whole body preferred) within the past 8 weeks
- Chest x-ray (or CT) of the chest within the past 8 weeks to exclude distant metastases (except for patients who have had whole body PET-CT)
- Transrectal ultrasound (TRUS) within the past 8 weeks required to establish tumor stage
- TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion
- No synchronous primary colon carcinoma
- No evidence of distant metastases (M1)
- ANC ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
- AST \< 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase \< 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance \> 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years
Exclusion
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
- Evidence of peripheral neuropathy ≥ grade 2
- Prior allergic reaction to capecitabine
- Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00973778
Start Date
July 1 2009
End Date
July 1 2012
Last Update
June 15 2011
Active Locations (2)
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1
Department of General Surgery, Shanghai Ruijin Hospital
Shanghai, China, 200035
2
Department of Oncology, Shanghai Ruijin Hospital
Shanghai, China, 200035