Clinical trial NCT00336609: TRIAD Burden of Illness Mucositis Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)
Lead sponsor: TRIAD Burden of Illness
Sponsor class: OTHER
First posted: 2006-06-14
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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 various cancer types.

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.

Eligibility 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:

  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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Univeristy Of Wisconsin
state: Wisconsin
Study officials:
affiliation: Brigham and Women's Hospital
name: Sonis T Sonis, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Adelaide
name: Dorothy Keefe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Linda Elting, MD
role: PRINCIPAL_INVESTIGATOR
References: