MDACC Study Summary 2008-0632

Study Summary
No. 2008-0632:.......Gastrointestinal; Lung......Thomas Guerrero......Radiation Oncology

Study Summary Title



Study Summary Number:	2008-0632

Study Title:	A phase II study to test the correlation of a radiation pneumonitis imaging biomarker with clinical and molecular endpoints

Physician

New Patient Referral



Name:	Thomas Guerrero	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:	Gastrointestinal Lung	Supported By:	NCI

Phase of Study:	Phase II	Return Visit:	The patients recruited to this study are already scheduled to receive 18F-FDG PET/CT imaging for restaging as part of their cancer treatment management. No post-treatment evaluation is required.

Treatment Agents:	Nitric oxide	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to use a new breathing test that measures the amount of nitric oxide (NO) you exhale. Researchers want to compare your "NO" levels to the amount of inflammation in your lungs, as measured using a PET scan reading, and with respiratory symptoms questionnaire.

Study Objectives / Outcomes

Ÿ To determine the correlation between the pulmonary metabolic radiation response (PMRR) and the fraction of exhaled alveolar nitric oxice (NO).
Ÿ To evaluate the reproducibility of the fraction of exhaled alveolar NO in a single setting.
Ÿ To evaluate the ability of blood derived molecular biomarkers obtained during RT to predict post-RT clinical RP symptoms and the PMRR.
Ÿ Estimate the area under the ROC curve (AUROC) for predicting radiation pneumonitis (RP) based on the ratio between the end-of-radiotherapy NO measurements and baseline NO measurements (ratio) in patients with esophagus or lung cancer undergoing radiation therapy.
Ÿ Measure the transient elevation in exhaled NO after CT imaging for radiation therapy simulation.

Study Status Information



Study Activation / Registration Date:	03/20/2009

IRB Review and Approval Date:	02/18/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

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) Patients with pathologic diagnosis of esophagus cancer.

2) For the cohort 2, patients with the pathological diagnosis of lung cancer.

3) For the cohort 3, patients with any pathological diagnosis of a thoracic malignancy.

4) Patients must sign informed consent.

5) Patients who will receive concurrent chemotherapy and radiation therapy will be undergoing PET-scan for restaging between 25 and 75 days after radio therapy.

6) For Lung Cohort, patients who will receive concurrent chemotherapy and radiation therapy or greater or equal to 3 weeks of radiation therapy alone.

7) For the Lung Cohort, participation in a PET-scan for restaging between 40-50 days after radiotherapy is required. 10 patients will receive a second PET-scan within 2-7 days as a test for reproducibility.

Exclusion Criteria:

1) Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.

2) Patients who received thoracic radiotherapy prior to the study.

Links

Registration Number: NCT00867477
Study Information on Clinical Trials Registry (clinicaltrials.gov)