Status:
COMPLETED
Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence...
Detailed Description
There are 2 types of radiation treatment being used in this study. One type of treatment is proton therapy. Proton therapy is a type of radiation therapy that uses a beam of proton particles (similar ...
Eligibility Criteria
Inclusion
- Pathologically proven, unresected, locoregionally advanced NSCLC without evidence of hematogenous metastases (stage II-IIIB disease according to the 7th edition of the AJCC Staging Manual) with exception as defined by inclusion #2).
- Patients with solitary brain metastasis without sign of progression in the brain at the time of registration will be eligible for this trial if there is clinical indication for concurrent chemoradiation to the primary disease in the lung.
- Suitability for concurrent chemoradiation therapy per treating radiation oncologists or treating medical oncologist's: A) Karnofsky performance score of \>/= 70, or ECOG 0-1 B) Unintentional weight loss \</= 10% during the 3 months before study entry.
- Receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed for this protocol.
- Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan.
- Locoregional recurrence after surgical resection, if suitable for definitive concurrent chemoradiation is allowed for this protocol.
- Forced expiratory volume in the first second (FEV1) \>/= 1 liters.
- Fluorodeoxyglucose (FDG) -PET scan within 3 months before registration. The pretreatment (diagnostic) PET/CT should, whenever possible, be performed together with the 4-D CT simulation. PET images acquired either at the time of simulation or acquired separately should be registered with the planning CT to assist in tumor delineation.
- Standard pretreatment evaluations (as decided by treating radiation oncologist, medical oncologist, surgeons or pulmonologist), to include MRI or CT scan of the brain, contrast CT scan of the thorax and upper abdomen, Whole-body PET/CT, pulmonary function tests, lung and cardiac single proton emission computed tomography (SPECT), liver function tests (LFT), blood chemistry, renal function tests, and complete blood count.
- Age \>/= 18 years but \</= 85 years.
- A signed specific informed consent form before study entry.
Exclusion
- Small cell histology.
- Prior thoracic radiotherapy to regions that would result in overlap of radiation therapy fields.
- Pregnancy (female patients of childbearing potential must practice appropriate contraception).
- Enrollment in a clinical trial that specifically excludes IGAPT treatment.
- Body weight exceeds the weight limit of the treatment couch.
- Oxygen dependent due to preexistent lung disease (COPD, emphysema, lung fibrosis).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2020
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00915005
Start Date
June 1 2009
End Date
February 24 2020
Last Update
May 26 2020
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77007