CompletedPhase 1NCT01486602

Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

This phase I trial studies the side effects and the best dose of hypofractionated radiation therapy when given together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.

Checked against the public recordLast updated Jan 19, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations11
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
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

1. Histologically or cytologically documented non-small cell lung cancer 2. Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible 3. Thoracic disease without supraclavicular or contralateral hilar involvement 4. When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; exudative pleural effusions are excluded regardless of cytology; patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible 5. No prior radiotherapy or chemotherapy for NSCLC 6. No prior mediastinal or thoracic radiotherapy 7. Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible 8. Patients must have measurable disease * Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral CT scan * Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 10. No patients that are known to be pregnant or nursing 11. Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase \[SGOT\]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance \>= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted

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

  • Mayo Clinic HospitalPhoenix, Arizona
  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • Moores University of California San Diego Cancer CenterLa Jolla, California
  • University of ChicagoChicago, Illinois
  • University of Maryland/Greenebaum Cancer CenterBaltimore, Maryland
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • State University of New York Upstate Medical UniversitySyracuse, New York
  • University of North Carolina - Chapel HillChapel Hill, North Carolina
  • Wake Forest University Health SciencesWinston-Salem, North Carolina
  • Rhode Island HospitalProvidence, Rhode Island
  • University of VermontBurlington, Vermont

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 19, 2018. Always confirm current availability with the study team.

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