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

June 12, 2006
April 19, 2007
November 2005
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Complete list of historical versions of study NCT00336609 on ClinicalTrials.gov Archive Site
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TRIAD Burden of Illness Mucositis Study
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

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
May 2007
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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
Both
18 Years and older
No
Contact: Stephen T Sonis, DMD, DMSc. 617 525-6864 ssonis@partners.org
United States
 
NCT00336609
No. 200509024
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TRIAD Burden of Illness
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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
TRIAD Burden of Illness
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP