MDACC Study Summary 2007-0322

Study Summary
No. 2007-0322:.......Rectum......John Skibber......Surgical Oncology

Study Summary Title



Study Summary Number:	2007-0322

Study Title:	A Pilot Study for Prospective Discovery of Possible Relationship Between Quality of Life, Treatment Modalities, and Patient Treatment/Outcome Expectations in Patients Undergoing Treatment for Locally Recurrent Rectal Adenocarcinoma

Physician

New Patient Referral



Name:	John Skibber	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:	Donor Funds

Phase of Study:	N/A	Return Visit:	Patients will return to clinic according to the requirements of their treatment plan. Patients will not be required to come to MDACC solely to respond to the requirements of this study.

Treatment Agents:	None	Home Care:	Questionnaires may be completed at home if patient is not scheduled to return to clinic for standard-of-care followup and is not hospitalized during the evaluation period.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this study is to learn how the treatment given to patients with recurrent rectal cancer affects their well being and quality of life.

Study Objectives / Outcomes

Primary Objective:
Estimate the association between baseline and post-baseline patient-reported pain responses, patient reported symptoms, and information obtained through review of patient PET (positron emission tomography) scans.

Secondary Objectives:

1. Assess and estimate the potential association between the change of Quality of LIfe (QOL), patient expectations during treatment, effectiveness of treatment, and pain management in patients with recurrent rectal carcinoma.

2. Develop and maintain a prospective database of patients with recurrent rectal cancer.

Study Status Information



Study Activation / Registration Date:	03/12/2008

IRB Review and Approval Date:	01/28/2008

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

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) All patients who have had previous surgical treatment of rectal adenocarcinoma, regardless of age, with locally recurrent (pelvic) rectal adenocarcinoma are eligible, if a period of at least 3 months exists between initial treatment and disease recurrence.

2) Patients may have local recurrence alone, or concurrent distant metastatic disease. Patients must have recurrent rectal cancer present in the bony pelvis.

3) Patients must be conversant in English in order to complete appropriate questions.

4) Patients must understand the test and questionnaire parameters, including the need for PET testing to assess the correlation between perceived symptoms and PET results. Patients must be able and willing to complete all scheduled appointments and complete and return all study questionnaires.

Exclusion Criteria:

1) Patients may not have non-adenocarcinoma pathology, i.e., squamous cell carcinoma of the anus, cloacogenic tumors, etc.

2) Patients may not have any concurrent pelvic malignancy in addition to rectal carcinoma.

3) Patients may not have ONLY distant metastases. Recurrence must be present within the bony pelvis.

4) Patients may not have a history of either a documented pelvic pain syndrome or a preoperative documented diagnosis of chronic constipation (defined as < 1 BM per 48 hours, unrelated to rectal cancer or mechanical obstruction) preceding the cancer diagnosis.

5) Patient may not have had solely non-operative therapies in treatment of their primary rectal carcinoma.

Links

Registration Number: NCT00648635
Study Information on Clinical Trials Registry (clinicaltrials.gov)