Image-Guided Adaptive Conformal Photon Versus Proton Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00915005
First received: June 4, 2009
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Radiation: Photon Therapy
Radiation: Proton Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Tumor Recurrence [ Time Frame: 4-8 weeks after completion of chemoradiation, then every 3-4 months for 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Experimental: Group 3
Group 3: Proton treatment at a lower dose level and/or reduced length of radiation - 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915005

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77007
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Zhongxing Liao, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00915005     History of Changes
Other Study ID Numbers: 2008-0133, NCI-2011-01094, 2 PO1 CA021239-29A1
Study First Received: June 4, 2009
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

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
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pneumonia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 31, 2014