Assessment of the Impact of Systemic Chemotherapy on the Quality of Life (QOL) in Patients with Metastatic Appendiceal Epithelial Neoplasms (AEN)
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.
Disease Group: Advanced Cancers
Treatment Agent: None
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: Patients can be treated on an outpatient basis for this disease.
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.
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.
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.
IRB Review and Approval Date: 06/16/2008
Recruitment Status: Closed
Projected Accrual: N/A
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.
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).
Phone Number: 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
clinicaltrials.gov NCT No: Not Applicable Clinical Trial