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Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer



- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated
hypofractionated radiotherapy with concurrent chemotherapy.


- To evaluate the rate of radiographic response to treatment.

- To estimate the rates of progression: local/regional/distant.

- To estimate the progression-free survival.

- To estimate the overall survival.

OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated

Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over
30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients also undergo accelerated
hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or
intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to
5.5 weeks.

Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Histologically or cytologically documented non-small cell lung cancer (NSCLC)

- Stage: IIIA or IIIB NSCLC; patients who present with N2 or N3 disease and an
undetectable primary tumor are also eligible

- Tumor Site: Thoracic disease without supraclavicular or contralateral hilar

- Pleural Effusion: 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

- 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


- ECOG performance status 0-1

- No patients that are known to be pregnant or nursing

- Granulocytes ≥ 1,500/μl

- Platelet count ≥ 100,000/μl

- Bilirubin ≤1.5 times upper limit of normal (ULN)

- AST (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


- No prior radiotherapy or chemotherapy for non-small cell lung cancer (NSCLC)

- No prior mediastinal or thoracic radiotherapy

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum-tolerated RT dose fraction

Safety Issue:


Principal Investigator

James J. Urbanic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University



Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mayo Clinic ScottsdaleScottsdale, Arizona  85259
University of Chicago Cancer Research CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Mayo Clinic HospitalPhoenix, Arizona  85054-4502