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
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| ClinicalTrials.gov Identifier: NCT00915005 |
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Recruitment Status :
Active, not recruiting
First Posted : June 5, 2009
Last Update Posted : February 13, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small-Cell Lung Carcinoma | Radiation: Photon Therapy Radiation: Proton Therapy Drug: Paclitaxel Drug: Carboplatin | Phase 2 |
Show Detailed Description
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
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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 |
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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 |
- 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.
- Time to Development of CTCAE v3.0 grade > 3 Treatment Related Pneumonitis (TRP) [ Time Frame: 4-8 weeks after completion of chemoradiation ]
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 </= 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 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915005
| 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 | |
| Study Chair: | Zhongxing Liao, MD | M.D. Anderson Cancer Center |
Additional Information:
| 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 Key Record Dates |
| 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:
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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:
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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 |