MDACC Study Summary ACOSOGZ6041 (Archived)

Study Summary
No. ACOSOGZ6041:.......Rectum......Miguel A. Rodriguez-Bigas......Surgical Oncology

Study Summary Title



Study Summary Number:	ACOSOGZ6041

Study Title:	A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for uT2uN0 Rectal Cancer

Physician

New Patient Referral



Name:	Miguel A. Rodriguez-Bigas	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6940 Contact us about clinical trials

General Information



Disease Group:	Rectum	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will return for follow-up visits at 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 42, 48, 54, and 60 months, post-surgery.

Treatment Agents:	Capecitabine Oxaliplatin	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Standard length of stay for surgery.


Description/ Intervention:	The goal of this clinical research study is to test the effectiveness of giving a combination of chemotherapy (drugs given to fight cancer) and radiation treatment before surgery to remove the cancer, in patients with rectal cancer. The safety of this combination treatment will also be studied, as well as its effect on your quality of life.

Study Objectives / Outcomes

Primary Objective

To determine the rate of disease-free survival at 3 years in ultrasound-staged uT2uN0 rectal cancer patients treated with CRT followed by local excision (LE).

Disease-free survival is defined as: no evidence of death, and no evidence of recurrence or distant metastasis on clinical, radiological, or ultrasound exam at the specified time.

Secondary Objectives

To determine the rate of resectability with negative margins in ultrasound-staged uT2uN0 rectal cancer treated with neoadjuvant CRT followed by LE.

To determine the procedure-specific morbidity and mortality following neoadjuvant CRT and LE.

To determine the rate of pathologic complete response of the primary tumor to a CRT regimen including capecitabine plus oxaliplatin.

To explore the impact of neoadjuvant CRT followed by LE on anorectal function and quality of life.

To explore the feasibility of using molecular studies to assess surgical resection margins and tumor response to neoadjuvant CRT.

To explore molecular markers associated with local tumor recurrence.

Study Status Information



Study Activation / Registration Date:	02/28/2006

IRB Review and Approval Date:	01/04/2006

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	102

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient must be at least 18 years of age.

2) Patient must have an ECOG/Zubrod status of less than or equal to 2.

3) Patient must have histologically confirmed invasive adenocarcinoma of the rectum. Note: Patients with rectal tumors suspicious for invasion also are eligible.

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

5) Patients must have adequate bone marrow, hepatic and renal function prior to registration: a) wbc greater than or equal to 3,000/mm(3), b) ANC greater than 1,500/mm(3), c) Hemoglobin greater than 9.5 mg/dl, d) Platelet count greater than or equal to 100,000/mm(3), e) Total bilirubin less than or equal to 3 mg/dl, f) AST (SGOT) less than or equal to 2.0 times institutional upper limit of normal (ULN), g) ALT (SGPT) less than or equal to 2.0 times ULN h) Alkaline phosphatase less than or equal to 2.0 times ULN

6) Continued from Inclusion Criteria 6 - i) Creatinine clearance (CLcr) greater than or equal to 50 cc ml/min by Cockroft-Gault Equation: Male= (140-age)xweight(72 X serum creatine); female=(140-age)xweight(72 X serum creatine)x 0.85

7) 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).

8) 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.

Exclusion Criteria:

1) Patients with tumors fixed to adjacent structures on digital exam.

2) Patients with uT1, uT3, or uT4 tumors.

3) Patients with positive perirectal nodes on ERUS examination.

4) Patients with histologic evidence of metastatic invasion of inguinal lymph nodes.

5) Patients with metastatic disease or other primary tumors (patients treated for non-melanoma skin carcinoma, are in-situ carcinoma) diagnosed less than five years prior to the current diagnosis of rectal cancer will not be eligible to participate in this trial (patient must have had Chest X-ray/CT and Abdominal & Pelvic CT/MRI with IV contrast, as well as a colonoscopy).

6) Patients with previously documented history of Familial Adenomatous Polyposis.

7) Patients with previously documented history of hereditary non-polyposis colorectal cancer diagnosed clincally (Amsterdam II criteria) or by genetic testing.

8) History of inflammatory bowel disease.

9) History of prior radiation treatments to pelvis.

10) Patients with clincally 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).

11) Patients with history of any clincally significant cardiac disease (i.e. Class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrythmia, and/or myocardial infarction within the last 6 months).

12) Patients with history of uncontrolled seizures or clincally significant central nervous system disorders.

13) Patients with history of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance.

14) Patients with history of allergy and/or hypersensitivity to Capecitabine and/or Oxaliplatin.

15) Patients with history of difficulty or inability to take or absorb oral medications.

Links

Registration Number: NCT00114231
Study Information on Clinical Trials Registry (clinicaltrials.gov)