MDACC Study Summary 2005-1001 (Archived)

Study Summary
No. 2005-1001:.......Breast; Colorectal; Head And Neck; Lung; Ovary......Adam Garden......Radiation Oncology

Study Summary Title



Study Summary Number:	2005-1001

Study Title:	Risk and Outcomes of Mucositis During and After Treatment for Breast, Colorectal, Head and Neck, or Non-small Cell Lung Cancers or Non-Hodgkin's Lymphoma

Physician

New Patient Referral



Name:	Adam Garden	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Breast Colorectal Head And Neck Lung Ovary	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients will be seen during their regularly scheduled treatment visits

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	n/a

Description/
Intervention:

The goal of the Initial Phase of this clinical research study is to determine
the number of patients that develop mouth and gastro-intestinal (GI) sores or
diarrhea as a result of their cancer treatment. The impact of these side
effects on the patients' quality of life will also be studied.

The goal of the Chronic Effects Phase is to understand the long-term effects of
mucositis. This phase of the study will try to estimate the risk of developing
symptoms of mucositis between 6 and 12 months after the end of the cancer
treatment. The impact of these side effects on your quality of life will also
be studied.

Study Objectives / Outcomes

Primary Objectives - Initial Phase:
1. To estimate the risk of patient-reported oral and/or gastrointestinal (GI) mucosal injury among subjects being treated with chemotherapy or radiation therapy for solid tumors.
2. To describe the concordance between patient-reported oral mucosal injury and clinician-reported oral mucosal injury.

Secondary Objectives- Initial Phase:

1. To describe the clinical, patient-reported, and economic outcomes of mucosal injury,
by grade of mucositis.

a. To estimate the risk of adverse clinical outcomes (modification of cancer

therapy dosing, drug selection, or treatment schedule) and adverse

economic outcomes (proportions of subjects requiring hospitalization,

TPN, narcotic analgesics, ER visits) among subjects with mucosal injury,

by grade of mucositis.

b. To describe patient-reported outcomes (mean quality of life and daily

functioning scores during mucosal injury and changes from baseline)

among patients with mucosal injury, by grade of mucositis, and to

determine the association between the presence and severity of mucosal

injury and important patient-reported outcomes including health-related

quality of life and daily functioning.

2. To compare adverse clinical, patient-reported, and economic outcomes among those
who develop mucosal injury, by grade, with those who do not develop mucosal injury; to
describe the association between the presence and severity of mucosal injury and risk of
important clinical and economic outcomes; and to derive an estimate of cost of treatment
of mucosal injury.
3. To compare the risk and severity of mucosal toxicity a) across regimens, within tumor
groups and b) across tumor groups, within treatment regimens.
4. To model the risk and severity of mucositis based on demographic and treatment
variables.
5. To describe the association between the presence and severity of mucositis and other
cancer-related toxicities, such as fatigue, weight loss, and cachexia.

Study Status Information



Study Activation / Registration Date:	06/08/2006

IRB Review and Approval Date:	02/08/2006

Study Type:	Observational

Recruitment Status:	Terminated

Projected Accrual:	742

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Signed informed consent

2) Subjects 18 years or older.

3) For the Initial Phase of the study,Membership in one of the following cohorts:(a.) 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. (b.) Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) or IMRT +/- chemotherapy.

4) cont from # 3: (c.) 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. (d.) 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. This cohort was discontinued after accruing 17 subjects. (e.) Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC. This cohort was discontinued after accruing 18 subjects.

5) cont from # 3: (f.) Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine. This cohort was discontinued after accruing 9 subjects (g.) 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). This cohort was discontinued after accruing 35 subjects. (h.) Non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- chemotherapy.

6) 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. This cohort was discontinued after accruing 9 subjects.

7) For the Chronic Effects Phase of the Study, Completion (defined as the last cycle of chemotherapy or completion of radiation therapy) of one of the following anti-neoplastic treatment regimens: a) Histologically proven oral cavity or oropharyngeal cancers that have received a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy. b) Histologically proven laryngeal or hypopharyngeal cancers that have received a full cycle of daily single fraction radiation (with or without boost) or IMRT +/- chemotherapy.

8) cont. from #7: c) Histologically proven adenocarcinoma of the colon or rectum that has received a minimum of 2 cycles of FOLFOX +/- bevacizumab or cetuximab.1 cycle defined as 2 doses of FOLFOX. d) Non-small cell lung cancers that have received daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- chemotherapy.

9) Successful completion of the initial phase of the study.

Exclusion Criteria:

1) Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis.

2) Receiving investigational treatment for the prevention or treatment of mucositis.

3) Received or planned to receive Amifostine.

4) For the Chronic Effects Phase of the study, received additional cancer therapy (RT or CT) following completion of the initial anti-neoplastic treatment regimen and the ROMC-TR100 study.

5) Any other significant event or finding in the subject's medical history or condition, which, in the opinion of the investigator, would preclude or alter the subject's ability to participate in the study.

Links

Registration Number: NCT00336609
Study Information on Clinical Trials Registry (clinicaltrials.gov)