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
Recruitment status was Recruiting
Sponsor:
TRIAD Burden of Illness
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
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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 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 |
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:
- 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.
- Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy.
- 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.
- 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.
- Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC.
- Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine.
- 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).
- 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.
- 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
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:
|
Lymphoma, Non-Hodgkin Mucositis Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013