TRIAD Burden of Illness Mucositis Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by TRIAD Burden of Illness.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
TRIAD Burden of Illness
ClinicalTrials.gov Identifier:
NCT00336609
First received: June 12, 2006
Last updated: April 19, 2007
Last verified: April 2007
  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)

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 19, 2014