CompletedPhase 2NCT00915005
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPhoton Therapy and Proton Therapy

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 26, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Radiation: Photon Therapy; Radiation: Proton Therapy; Drug: Paclitaxel; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 26, 2020. Always confirm current availability with the study team.

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