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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Sonis T Sonis, DMD, DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

No. 200509024

NCT ID:

NCT00336609

Start Date:

November 2005

Completion Date:

May 2007

Related Keywords:

  • Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)
  • Lymphoma, Non-Hodgkin
  • Mucositis

Name

Location

Univeristy Of WisconsinMadison, Wisconsin  53705