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Study Summary
No. 2008-0133:.......Lung......Zhongxing Liao......Radiation Oncology
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Study Summary Title
Study Summary
Number:		2008-0133
Study 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
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Physician New Patient Referral
Name:Zhongxing LiaoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:2 PO1 CA021239-29A1
Phase of Study:Phase IIReturn
Visit:		Once a week during the chemoradiation. Follow-up visit 4–8 weeks after
completion of the treatment, then every 3-4 months for 3 years, then every 6
months for to the next 2 years, and then annually thereafter.
Treatment
Agents:		Carboplatin
Chemotherapy
Paclitaxel
Proton Therapy		Home Care:n/a
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Primary Objective
· Assess and compare the incidence and time to development of CTCAE v3.0 grade > 3 treatment related pneumonitis (TRP) or local failure, 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. Serum of the blood samples will be transferred to collaborating laboratories at The Methodist Research Institute for analysis of specific biomarkers. All material transfer will follow institutional policy and all transferred material will be de-identified.
      • For the proposed research, we will use a rapid and high-throughput nanopore-based array to enrich low molecular weight (LMW) proteins to identify circulating LMW peptide markers in blood samples from patients with or without NSCLC. By optimizing the nanotexture of silica films through the engineering of the physicochemical properties (e.g., pore size, pore structure, surface affinity) on the nanoporous silica chip, we can selectively enrich low-abundance, LMW peptides from serum samples. We will process the samples on nanoporous silica chips for LMW protein fractionation, and analyze the isolated fractions by MALDI-TOF mass spectrometry and principal component analysis. LMW peptide signatures associated with lung cancer will be identified by LC-MS/MS.
        • 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.
              • For Group 3 and Group 4 patients who are treated with protons or photons depending on higher dose achievable, compare the local control, overall survival, progression-free survival, median survival and toxicities of protons vs. photons (see Section 7.5).
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              Study Status Information
              Study Activation / Registration Date:06/03/2009
              IRB Review and Approval Date:06/03/2009
              Study Type:Phase Ii Or Phase I/Ii
              Recruitment Status:Open
              Projected Accrual:250
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              Enrollment Eligibility
              If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
              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 pulmonalogist), 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).
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              Links
              Registration Number: NCT00915005
              Study Information on Clinical Trials Registry (clinicaltrials.gov)
              Other Links:
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              Results

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