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Trial record 1 of 1 for:    nct00915005
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00915005
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 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
Actual Primary Completion Date : February 24, 2020
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Carboplatin

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




Primary Outcome Measures :
  1. 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) [ Time Frame: From date of protocol registration until the date of first documented development of CTCAE v3.0 grade > 3 TRP or local failure, whichever occurs first, in both treatment groups, assessed up to 6 years. ]
    The Primary Objective is assess and compare the incidence and time to development of CTCAE v3.0 grade > 3 TRP, among IMRT-Group 1 or PSPT-Group 2 using Bayesian randomization. TRP will be diagnosed clinically by the treating investigator. Any questions regarding the diagnosis or grade of TRP will be resolved by the Protocol PI or by his/her designee(s). The outcomes review committee will meet to discuss each and every patient reported to have developed symptomatic TRP. The final grading of TRP will be decided by the outcomes review committee. Diagnosis of TRP included receipt of radiation that included a certain volume of normal lung, radiographic changes that suggested inflammation consistent with the radiation dose distribution within 12 months after starting chemoradiation, and symptoms attributable to TRP. Final TRP outcomes also were reviewed and approved by independent external experts.

  2. The Incidence and Time to Development of Local Failure (LF) [ Time Frame: From date of protocol registration until the date of first documented development of CTCAE v3.0 grade > 3 TRP or local failure, whichever occurs first, in both treatment groups, assessed up to 6 years. ]

    The Primary Objective is assess and compare the incidence and time to development of local failure, among IMRT-Group 1 or PSPT-Group 2 using Bayesian randomization. Local failure was defined as treatment failure within the planning target volume plus a # 1-cm margin. Images used to report Local failure were registered with radiation dose distribution to accurately assess the location of the failure. Biopsy to confirm Local failure was strongly recommended (Data Supplement). An internal outcomes review committee reviewed each event to ensure objectivity and consistency in reporting Local failure. Final RP outcomes also were reviewed and approved by independent external experts.

    1. Tumor recurrence after achieving complete response,
    2. Residual tumor enlargement of 20% or more on CT according to RECIST criteria,
    3. Recurrence of PET FDG Avidity after achieving complete metabolic response,
    4. Increase in FDG avidity in residual tumor,
    5. Pathologically proven recurrence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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).

Information from the National Library of Medicine

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


Locations
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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
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Study Chair: Zhongxing Liao, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol  [PDF] February 19, 2013
Statistical Analysis Plan  [PDF] February 19, 2013

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00915005    
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
Results First Posted: May 26, 2020
Last Update Posted: May 26, 2020
Last Verified: May 2020

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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:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pneumonia
Recurrence
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
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action