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TRIAD Burden of Illness Mucositis Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by TRIAD Burden of Illness.
Recruitment status was:  Recruiting
Information provided by:
TRIAD Burden of Illness Identifier:
First received: June 12, 2006
Last updated: April 19, 2007
Last verified: April 2007
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.

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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00336609

Contact: Stephen T Sonis, DMD, DMSc. 617 525-6864

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
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 Identifier: NCT00336609     History of Changes
Other Study ID Numbers: No. 200509024
Study First Received: June 12, 2006
Last Updated: April 19, 2007

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on April 27, 2017