TRIAD Burden of Illness Mucositis Study

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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00336609
• Other study ID #: No. 200509024
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2006
• Last updated: April 19, 2007
• Start date: November 2005
• Est. completion date: May 2007

Study information

• Verified date: April 2007
• Source: TRIAD Burden of Illness
• Contact: Stephen T Sonis, DMD, DMSc.
• Phone: 617 525-6864
• Email: ssonis[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 various cancer types.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Univeristy Of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
TRIAD Burden of Illness

Country where clinical trial is conducted

United States,