TRIAD Burden of Illness Mucositis Study - Full Text View

Sponsored by:	TRIAD Burden of Illness
Information provided by:	TRIAD Burden of Illness
ClinicalTrials.gov Identifier:	NCT00336609

Purpose

Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.

Condition
Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study
Official Title:	Risk and Outcomes of Mucositis in Subjects Being Treated for Breast, Colorectal, Head and Neck, Non-Small Cell Lung Cancers or Non-Hodgkin's Lymphoma

Further study details as provided by TRIAD Burden of Illness:

Estimated Enrollment:	1600
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2007

Detailed Description:

This comprehensive, observational study will prospectively elicit the true incidence (risk) and health and economic burdens of mucosal toxicities associated with anti-cancer drug and radiation therapy. This study will examine the burden of illness of gastrointestinal mucositis (defined as mucositis involving the mouth, esophagus, or small intestine) in the most significant regimens used to treat the most common types of cancers. It is an international investigation in which 1600 patients being treated with specific regimens for cancers of the head and neck, breast, colon, lung (NSCLC)and Non-Hogkin's Lymphoma will be prospectively enrolled from centers throughout the US, Canada, Europe and Australia.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Ability to understand the protocol and willing to provide written informed consent
Membership in one of the following sub-cohorts:
1. Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy.
2. Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy.
3. Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFOX +/- Avastin or Erbitux.1 cycle defined as 2 doses of FOLFOX.
4. Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFIRI +/- Avastin or Erbitux. 1 cycle defined as 2 doses of FOLFIRI.
5. Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC.
6. Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine.
7. Adenocarcinoma of the breast planned to receive standard or dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) (4 cycles AC followed by 2 cycles T).
8. Stage 3A or 3B non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- Carbo/Taxol.
9. B-cell Non-Hodgkin’s lymphoma (NHL) planned to receive at least 2 cycles of CHOP-14, CHOEP-14, CHOP-DI-14, EPOCH-14 or CHOP-21 +/- rituxan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336609

Contacts

Contact: Stephen T Sonis, DMD, DMSc.

617 525-6864

ssonis@partners.org

Locations

United States, Wisconsin
Univeristy Of Wisconsin	Recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Paul M Harari, MD

Sponsors and Collaborators

TRIAD Burden of Illness

Investigators

Principal Investigator:	Sonis T Sonis, DMD, DMSc	Brigham and Women's Hospital
Principal Investigator:	Dorothy Keefe, MD	University of Adelaide
Principal Investigator:	Linda Elting, MD	M.D. Anderson Cancer Center

More Information

Study ID Numbers:	No. 200509024
Study First Received:	June 12, 2006
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00336609
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Mouth Diseases
Non-small cell lung cancer
Digestive System Diseases
Mucositis
Gastrointestinal Diseases
Lung Neoplasms

Lymphoma, small cleaved-cell, diffuse
Stomatognathic Diseases
Gastroenteritis
Lymphoma, Non-Hodgkin
Carcinoma, Non-Small-Cell Lung
Lymphoma

ClinicalTrials.gov processed this record on January 16, 2009