MDACC Study Summary 2007-0769

Study Summary
No. 2007-0769:.......Advanced Cancers; Gastrointestinal......Cathy Eng......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2007-0769

Study Title:	Assessment of the Impact of Systemic Chemotherapy on the Quality of Life (QOL) in Patients with Metastatic Appendiceal Epithelial Neoplasms (AEN)

Physician

New Patient Referral



Name:	Cathy Eng	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-794-1843 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Gastrointestinal	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Following treatment, which can be received at an outside institution if necessary, study subjects must return to MDACC for follow-up surveillance visits every 3 months (+/- 1 month) for one year.

Treatment Agents:	None	Home Care:	Systemic chemotherapy given to treat patients while they are enrolled in this study can be taken either in a hospital on an outpatient basis, either at MDACC or at another institution, or in the home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Patients can be treated on an outpatient basis for this disease.


Description/ Intervention:	The goal of this research study is to learn if systemic chemotherapy including 5-fluorouracil can help to improve the quality of life in patients with cancer of the appendix that has spread to the abdomen.

Study Objectives / Outcomes

PRIMARY OBJECTIVE:

1. Determine if systemic chemotherapy will improve the quality of life (QOL) in appendiceal epithelial neoplasms (AEN) patients who are not candidates for surgical debulking following 6 months of chemotherapy versus baseline.

Study Status Information



Study Activation / Registration Date:	06/16/2008

IRB Review and Approval Date:	06/16/2008

Study Type:	Behavioral

Recruitment Status:	Closed

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) Patients must have histological evidence of a metastatic appendiceal epithelial neoplasm (AEN).

2) Patients must have clinical evidence of progression, intolerance of prior therapy, or tumor marker evidence of progression.

3) Patients must agree to receive 5-FU-based systemic chemotherapy.

4) Patients may agree to receive their systemic chemotherapy outside MDACC but must agree to be evaluated at MDACC for their baseline radiological and restaging studies every 3 months (+/- 1 month) for one year.

5) Age greater than or equal to 16 years old.

6) Patients must be able to understand and provide answers to the EORTC QLQ-C30/OV-28 QOL questionnaires in order to participate in the trial.

7) Radiological baseline studies shall be completed within 6 weeks of initiation of therapy.

8) Patients with a prior history of non-AEN may be included if there is no evidence of malignancy for at least 5 years from last treatment and no evidence of recurrence. In addition, patients with completely resected non-melanoma skin cancer or cervical carcinoma in-situ may be included.

Exclusion Criteria:

1) Patients with AEN of any other histology besides pseudomyxoma peritonei (PMP), mucinous adenocarcinoma, or signet ring carcinoma.

2) Patients who will not be followed at MDACC for subsequent visits.

3) Patients with psychiatric illness/social situations that would limit compliance with study requirements are excluded.

4) Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).

Links

Registration Number: Not Applicable Clinical Trial