Phase 2
N=181
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
Non-Small-Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00915005 ↗Enrolled (actual)
181
Serious AEs
33.6%
Results posted
May 2020
Primary outcome: Primary: The Incidence and Time to Development of Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) Grade > 3 Treatment-related Pneumonitis (TRP) — 2; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Photon Therapy (Radiation); Proton Therapy (Radiation); Paclitaxel (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence and Time to Development of Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) Grade > 3 Treatment-related Pneumonitis (TRP) |
2; 0; 0; 0; 6; 6 | — |
| PRIMARY The Incidence and Time to Development of Local Failure (LF) |
18; 14; 10; 6 | — |
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 (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
Eligibility Criteria
Inclusion Criteria
- 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 /= 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00915005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.