Andrew A. Shelton, M.D.
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: capecitabine
- Drug: oxaliplatin
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Procedure: radiation therapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the rectum
o T2, N0 (stage I) disease by endorectal ultrasound (ERUS) scan
a. No T1, T3, or T4 disease
b. No tumors fixed to adjacent structures by digital exam
c. Greatest tumor diameter <= 4 cm
d. Distal border of the tumor must be <= 8 cm from the anal verge by rigid proctoscopic exam
o No positive perirectal nodes by ERUS scan
o No histologic evidence of metastatic invasion of inguinal lymph nodes
- No metastatic or other primary disease by chest x-ray/CT scan, abdominal and pelvic CT scan/MRI with contrast, and colonoscopy
- No documented history of familial adenomatous polyposis
- No documented history of hereditary non-polyposis colorectal cancer diagnosed clinically or by genetic testing
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC >= 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 9.5 mg/dL
- Platelet count >= 100,000/mm^3
Hepatic
- AST and ALT <= 2.0 times upper limit of normal (ULN)
- Bilirubin <= 3 mg/dL
- Alkaline phosphatase <= 2.0 times ULN
Renal
- Creatinine clearance >= 50 mL/min
Cardiovascular
- No history of New York Heart Association class III-IV congestive heart failure
- No history of symptomatic coronary artery disease
- No history of uncontrolled arrhythmia
- No myocardial infarction within the past 6 months
- No history of any other clinically significant cardiac disease
Gastrointestinal
- No history of inflammatory bowel disease
- No history of difficulty or inability to take or absorb oral medications
Neurologic
- No clinically significant peripheral sensory or motor neuropathy
- No history of uncontrolled seizures or clinically significant central nervous system disorder
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy and/or hypersensitivity to capecitabine or oxaliplatin
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin carcinoma or in situ carcinoma
- No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the pelvis
- No concurrent intensity modulated radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational drugs
- No other concurrent anticancer treatment
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal CancerAnticipated start date:
8/11/2008Lead Sponsor:
ACOSOGCollaborator(s):
- NCI
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Cross OverEndpoints:
Safety/EfficacyPrimary Outcomes:
- Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years
Secondary Outcomes:
- Rate of resectability as measured by the pathology report at surgery
- Procedure-specific morbidity and mortality rate as measured by NCI CTCAE one month after surgery
- Rate of pathologic complete response of the primary tumor as measured by RECIST at surgery
- Anorectal function and quality of life as measured by the fecal incontinence severity index, fecal incontinence quality of life questionnaire, and functional assessment of cancer therapy-colorectal questionnaire one year after surgery
- Feasibility of using molecular studies to assess surgical resection margins and tumor response as measured by ligation detection reaction-polymerase chain reaction after surgery
- Molecular markers associated with local tumor recurrence by several molecular techniques after completion of study treatment
Total Number to be Enrolled:
85Total Number to be Enrolled at Stanford:
3More Information
Secondary ID(s):
- ACOSOG-Z6041
- ACOSOGZ6041
- CDR0000433145
- NCT00114231
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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