Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 2006
End Date:December 2014

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A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer

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.

OBJECTIVES:

Primary

- Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma
of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine,
oxaliplatin, and radiotherapy followed by local excision.

Secondary

- Determine the rate of resectability with negative resection margins in patients treated
with this regimen.

- Determine the procedure-specific morbidity and mortality in patients treated with this
regimen.

- Determine the rate of pathologic complete response of the primary tumor in patients
treated with this regimen.

- Determine the impact of this regimen on anorectal function and quality of life in these
patients.

- Determine the feasibility of using molecular studies to assess surgical resection
margins and tumor response in patients treated with this regimen.

- Determine molecular markers associated with local tumor recurrence in patients treated
with this regimen.

OUTLINE: This is a non-randomized, multicenter study.

Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19,
22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35
and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after
completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with
T3 disease or positive resection margins after local excision undergo radical resection of
the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the
physician.

Quality of life is assessed at baseline and then 1 year after surgery.

After completion of study treatment, patients are followed at 1 month, every 4 months for 3
years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.

- Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2

- Patient must have histologically confirmed invasive adenocarcinoma of the rectum;
Note: patients with rectal tumors suspicious for invasion also are eligible

- Distal border of the patient's tumor must be within 8 cm from the anal verge as
measured on endoscopic exam

- Patients with tumors fixed to adjacent structures on digital exam are NOT eligible

- Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or
endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4
tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm

- Patients with positive perirectal nodes on ERUS examination are NOT eligible

- Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are
NOT eligible

- Patients with the following conditions are NOT allowed on study:

- Metastatic disease or other primaries (patient must have had chest X-ray/computed
tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a
colonoscopy)

- Previously documented history of familial adenomatous polyposis

- Previously documented history of hereditary non-polyposis colorectal cancer
diagnosed clinically (Amsterdam II criteria) or by genetic testing

- History of inflammatory bowel disease

- History of prior radiation treatments to pelvis

- Clinically significant peripheral sensory or motor neuropathy (defined as
symptomatic weakness, paresthesia or sensory alteration described to be
interfering with function, interfering with activities of daily living, disabling
or life-threatening)

- History of any clinically significant cardiac disease (i.e., class 3-4 congestive
heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia,
and/or myocardial infarction within the last 6 months)

- History of uncontrolled seizures or clinically significant central nervous system
disorders

- History of psychiatric conditions or diminished mental capacity that could
compromise the giving of informed consent, or interfere with study compliance

- History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin

- History of difficulty or inability to take or absorb oral medications

- White blood cells (WBC) >= 3000/mm^3

- Absolute neutrophil count (ANC) > 1,500/mm^3

- Hemoglobin > 9.5 mg/dl

- Platelet count >= 100,000/mm^3

- Total bilirubin =< 3 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0
times institutional upper limit of normal (ULN)

- Alkaline phosphatase =< 2.0 times ULN

- Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation

- Patients who have experienced a prior malignancy must have received potentially
curative therapy for that malignancy, and must be cancer-free for at least five years
from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin
carcinoma, or in-situ carcinomas)

- Patients of reproductive potential must agree to use an effective method of birth
control when undergoing treatments with known or possible mutagenic or teratogenic
effects; all female participants of childbearing potential must have a negative urine
or serum pregnancy test within two weeks prior to study registration
We found this trial at
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Pittsburgh, Pennsylvania 15232
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1200 S Cedar Crest Blvd
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1500 E Duarte Rd
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2220 Pierce Ave
Nashville, Tennessee 37232
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4800 Friendship Avenue
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Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center The Curtis and...
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105 West 8th Avenue
Spokane, Washington 99220
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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Beaver, Pennsylvania 15009
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
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Bridgeport, Connecticut 06606
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Clarksburg, West Virginia 26301
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Danbury, Connecticut 06810
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Dayton, Ohio 45406
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1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
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Dayton, Ohio 45420
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
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9000 North Main Street
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
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105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
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Greensburg, Pennsylvania 15601
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835 Sweitzer St
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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535 Barnhill Dr
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1600 Coraopolis Heights Road
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1514 Jefferson Highway
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Newport News, Virginia 23606
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4805 NE Glisan St
Portland, Oregon 97213
(503) 215-1111
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1100 Reid Pkwy
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(765) 983-3000
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
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Seneca, Pennsylvania 16346
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3130 N. County Rd. 25-A
Troy, Ohio 45373
(937) 440-4000
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1141 N Monroe Dr
Xenia, Ohio 45385
937-352-2005
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