Status:
UNKNOWN
TRIAD Burden of Illness Mucositis Study
Lead Sponsor:
TRIAD Burden of Illness
Conditions:
Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)
Eligibility:
All Genders
18+ years
Brief Summary
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 va...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
End Date :
May 1 2007
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00336609
Start Date
November 1 2005
End Date
May 1 2007
Last Update
April 20 2007
Active Locations (1)
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1
Univeristy Of Wisconsin
Madison, Wisconsin, United States, 53705