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Image-Guided Adaptive Conformal Photon Versus Proton Therapy
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, July 2009
First Received: June 4, 2009   Last Updated: July 20, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00915005
  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.

Primary Objective:

  • Assess and compare the incidence and time to development of CTCAE v3.0 grade > 3 treatment related pneumonitis (TRP) or locoregional recurrence, whichever comes first, among patients with locally advanced (stage II-IIIb and selected stage IV) non-small cell lung cancer (NSCLC) treated with image-guided adaptive photon therapy (IGAXT, group 1) or proton therapy (IGAPT, group 2) using Bayesian randomization.

Secondary Objectives:

  • Assess and compare the incidence and time to development of CTCAE v3.0 grade > 3 radiation esophagitis in treatment groups 1 and 2.
  • Investigate the association of inflammatory cytokines with the incidence and time to development of TRP and outcomes in treatment groups 1 and 2.
  • Investigate the association of relevant pharmacogenetic markers, biomarkers, and gene polymorphisms with the time to development of TRP and treatment outcomes in treatment groups 1 and 2.
  • Evaluate IGAXT using weekly computed tomography (CT) on-rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery.
  • Compare overall survival, progression-free survival, and median survival time in treatment groups 1 and 2.
  • Evaluate the role of functional imaging with FDG-PET in assessing and predicting the time to the development of TRP and tumor response.
  • Document and compare symptom burden weekly during treatment, monthly up to 6 month after the treatment, and at each follow-up visit by using the M. D. Anderson Symptom Inventory for Lung (MDASI-Lung) in treatment groups 1 and 2.

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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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, every 6 months for the next 2 years, and then 1 time every year after that. ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: June 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
Group 1: Photon Therapy
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.
Group 2: Experimental
Group 2: Proton Therapy
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: 60-74 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.

Group 3: Experimental
Group 3: Proton treatment at a lower dose level and/or reduced length of radiation
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: 60-74 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 6th 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.
  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.
  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 be performed together with the 4-D CT simulation. If PET/CT is not available, PET image acquired separately may be fused with the 4D CT.
  9. Standard pretreatment evaluations (as decided by treating radiation oncologists, medical oncologist, surgeons or pulmonologists), to include MRI or CT scan of the brain, contrast CT scan of the thorax and upper abdomen, 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 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. Patients with implanted device(s) that prohibit patients from having proton treatment (cardiac pace maker, defibrillator, neurotransmitter, etc).
  6. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915005

Contacts
Contact: Zhongxing Liao, MD 713-563-2300

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77007
Principal Investigator: Zhongxing Liao, MD            
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: UT MD Anderson Cancer Center ( Zhongxing Liao, MD / Associate Professor )
Study ID Numbers: 2008-0133
Study First Received: June 4, 2009
Last Updated: July 20, 2009
ClinicalTrials.gov Identifier: NCT00915005     History of Changes
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

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Recurrence
Pneumonia
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 03, 2009