MDACC Study Summary 2003-0529

Study Summary
No. 2003-0529:.......Anus; Cervix; Endometrial; Gastric; Gynecology; Pancreas......Charlotte C. Sun......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2003-0529

Study Title:	Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life

Physician

New Patient Referral



Name:	Charlotte C. Sun	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-745-4380 Contact us about clinical trials

General Information



Disease Group:	Anus Cervix Endometrial Gastric Gynecology Pancreas	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Return visits as scheduled according to patient's chemoradiation treatment plan

Treatment Agents:	Interview Questionnaire	Home Care:	not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	not applicable


Description/ Intervention:	The goal of this research study is to find out more about a person's perceptions of side effects of chemoradiation. Another goal of the study is to see what kind of side effects patients actually experience during chemoradiation and how this affects their quality of life.

Study Objectives / Outcomes

1) To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.

1.1 To compare preferences of cancer patients to those of healthy individuals.
1.2 To compare how patients' preferences for side-effects of chemoradiation change over time.

2) To assess the longitudinally assess quality of life of cancer patients scheduled to receive chemoradiation.

3) To determine the impact of nausea and vomiting associated with chemoradiation on patients quality of life and evaluate potential change throughout the duration of chemoradiation treatment.

Study Status Information



Study Activation / Registration Date:	04/07/2004

IRB Review and Approval Date:	11/19/2003

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	200 participants (100 patients and 100 caregiver controls)

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 receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophogeal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]

2) Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).

3) Patients must be least 18 years of age

4) Controls must be individuals with no prior cancer diagnosis

5) Controls must be at least 18 years of age

6) Controls must be the caregivers of patients on this study

Exclusion Criteria:

1) Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer

2) Patients who are not scheduled to receive chemoradiation treatment

3) Patients who are not at least 18 years of age

4) Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)

5) Controls - individuals who are not at least 18 years of age

Links

Registration Number: NCT00394602
Study Information on Clinical Trials Registry (clinicaltrials.gov)