Return to List

Study Summary
No. 2010-0164:.......Lung......Daniel Gomez......Radiation Oncology
.
Study Summary Title
Study Summary
Number:
2010-0164
Study Title:Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
.
Physician New Patient Referral
Name:Daniel GomezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring 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:LungSupported By:N/A
Phase of Study:Phase IReturn
Visit:
Treatment
Agents:
Proton TherapyHome Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:
Unavailable
.
Study Objectives / Outcomes
The purpose of this study is to assess the safety of hypofractionated proton therapy in patients who are not candidates for concurrent chemotherapy in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), carcinoid, and thymic malignancies.


Primary Objectives
  • To assess the effect of hypofractionated dose escalation in the setting of proton therapy by measuring the incidence of acute dose-limiting toxicity (DLT). Inherent in this aim is the possible development of a maximum tolerated dose (MTD) using increasing fraction sizes.
  • To determine if a hypofractionated regimen at increased doses is well tolerated in patients that cannot tolerate standard chemotherapeutic regimens.

Secondary Objectives
  • To observe 1- and 2-year local control rates and to compare these outcomes to historical controls using standard fractionated regimens.
  • To observe patterns of exhaled alveolar nitric oxide and respiratory symptoms as delineated by the St. George's Respiratory Questionnaire after receiving hypofractionated proton therapy in thoracic malignancies.
  • To observe patterns of answers in the core MD Anderson Symptom Inventory Questionnaire after receiving hypofractioned proton therapy in thoracic malignancies.
.
Study Status Information
Study Activation / Registration Date:07/16/2010
IRB Review and Approval Date:07/16/2010
Study Type:Phase I
Recruitment Status:Closed
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) Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors

2) Patients not receiving concurrent chemotherapy

3) Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor [EGFR] or vascular endothelial growth factor [VEGF] inhibitors) will be eligible for the study.

Exclusion Criteria:1) Prior radiotherapy to the chest

2) Life expectancy <6 months

3) Pregnancy

.
Links
Registration Number: NCT01165658
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center