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NCT00502177

Quality of Life Study for Pediatric and Adult Patients Undergoing Hyperthermic Peritoneal Perfusion With Cisplatin

Completed Last updated 24 October 2018
What this trial tests

trial testing Questionnaire in Peritoneal Neoplasms in 48 participants. Completed in 29 August 2018.

Timeline
19 June 2007
Primary endpoint
29 August 2018
29 August 2018

Quick facts

Lead sponsorM.D. Anderson Cancer Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment48
Start date19 June 2007
Primary completion29 August 2018
Estimated completion29 August 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 1 to 18, any sex, with Peritoneal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives: The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2009-0528, "A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults with Desmoplastic Small Round Cell Tumor (DSRCT) and Other Non-carcinomas". Specific Aim 1: To examine the quality of life of patients who undergo HIPEC longitudinally. It is hypothesized that physical health and functioning concerns, as reported by parent/child dyads on the Pediatric Quality of Life Cancer Module Version 3.0 (PedsQL) and the PedsQL 4.0 Generic Core Scales, will will remain stable or improve, following the surgical procedures and peritoneal perfusion described in Protocol 2009-0528. Specific Aim 2: To assess parent and patient perception of the relative benefit of HIPEC longitudinally. It is hypothesized that parents and patients will perceive HIPEC to be beneficial across time, despite the temporary postoperative pain and discomfort that is associated with the procedure. This will be done by means of a non-validated question that is specific to the surgery. Exploratory Aim: To determine whether quality of life following HIPEC varies by demographic factors (e.g., age, culture), intraoperative cisplatin dose level, or subsequent treatment modalities. Some patients who undergo HIPEC might subsequently be treated with other Phase II chemotherapy agents and/or palliative radiation, and comparing quality of life in these subgroups will be of value. Also the quality of life for groups of patients enrolled in Protocol 2009-0528 at each intraoperative cisplatin dose level will be compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Questionnaire

Trials testing the same drug.

Other recruiting trials for Peritoneal Neoplasms

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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