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

Study Description

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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 (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.

Condition or disease	Intervention/treatment	Phase
Non-Small-Cell Lung Carcinoma	Radiation: Photon Therapy; Radiation: Proton Therapy; Drug: Paclitaxel; Drug: Carboplatin	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Bayesian Randomized 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
Actual Study Start Date :	June 2009
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group 1; Group 1: Photon Therapy - 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.	Radiation: Photon Therapy; Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Drug: Paclitaxel; 50 mg/m2 by vein 1 time each week for 7 weeks.; Other Name: Taxol Drug: Carboplatin; AUC 2 by vein 1 time each week for 7 weeks.; Other Name: Paraplatin
Experimental: Group 2; Group 2: Proton Therapy - 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.	Radiation: Proton Therapy; Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Drug: Paclitaxel; 50 mg/m2 by vein 1 time each week for 7 weeks.; Other Name: Taxol Drug: Carboplatin; AUC 2 by vein 1 time each week for 7 weeks.; Other Name: Paraplatin
Experimental: Group 3; Group 3: Receives either photon or proton therapy, whichever participant's doctor decides is better, for for 6-7 1/2 weeks. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.	Radiation: Photon Therapy; Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Radiation: Proton Therapy; Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Drug: Paclitaxel; 50 mg/m2 by vein 1 time each week for 7 weeks.; Other Name: Taxol Drug: Carboplatin; AUC 2 by vein 1 time each week for 7 weeks.; Other Name: Paraplatin
Experimental: Group 4; Photon Therapy - Highest practical dose (74 CGE, 66 CGE) radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Paclitaxel 50 mg/m2 by vein 1 time each week for 7 weeks. Carboplatin AUC 2 by vein 1 time each week for 7 weeks.	Radiation: Photon Therapy; Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete. Drug: Paclitaxel; 50 mg/m2 by vein 1 time each week for 7 weeks.; Other Name: Taxol Drug: Carboplatin; AUC 2 by vein 1 time each week for 7 weeks.; Other Name: Paraplatin

Outcome Measures

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Primary Outcome Measures :

1. Time to Treatment Failure [ Time Frame: 4-8 weeks after completion of chemoradiation ]
   Time to treatment failure, defined as interval from time of randomization to development of treatment-related pneumonitis (TRP) or local failure, whichever occurs first according to CTCAE v3.
2. Time to Development of CTCAE v3.0 grade > 3 Treatment Related Pneumonitis (TRP) [ Time Frame: 4-8 weeks after completion of chemoradiation ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. 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).
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.
3. 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.
4. Receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed for this protocol.
5. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan.
6. Locoregional recurrence after surgical resection, if suitable for definitive concurrent chemoradiation is allowed for this protocol.
7. Forced expiratory volume in the first second (FEV1) >/= 1 liters.
8. 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.
9. 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.
10. Age >/= 18 years but </= 85 years.
11. A signed specific informed consent form before study entry.

Exclusion Criteria:

1. Small cell histology.
2. Prior thoracic radiotherapy to regions that would result in overlap of radiation therapy fields.
3. Pregnancy (female patients of childbearing potential must practice appropriate contraception).
4. Enrollment in a clinical trial that specifically excludes IGAPT treatment.
5. Body weight exceeds the weight limit of the treatment couch.
6. Oxygen dependent due to preexistent lung disease (COPD, emphysema, lung fibrosis).

Contacts and Locations

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Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77007

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Zhongxing Liao, MD	M.D. Anderson Cancer Center

More Information

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Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00915005 History of Changes
Other Study ID Numbers:	2008-0133; NCI-2011-01094 ( Registry Identifier: NCI CTRP ); 2P01CA021239-29A1 ( U.S. NIH Grant/Contract )
First Posted:	June 5, 2009
Last Update Posted:	February 13, 2018
Last Verified:	February 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by M.D. Anderson Cancer Center:

Locally-advanced non-small-cell lung carcinoma; NSCLC; Lung Cancer; Image-Guided Adaptive Conformal Photon	Proton Therapy; Chemotherapy; Treatment Related Pneumonitis

Additional relevant MeSH terms:

Carcinoma; Recurrence; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pneumonia; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases	Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Infections; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action