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Phase III Randomized Study of Standard Versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Phase III Randomized Study of Standard Versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status


Inclusion Criteria:



- All patients must be willing and capable to provide informed consent to participate
in the protocol.

- Patients must have appropriate staging studies identifying them as AJCC stage II or
III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix
III), or recurrent non small cell lung cancer. Histologic confirmation of cancer
will be required by biopsy or cytology within 6 months of study entry.

- Patients must have the potential for benefit from local therapy (at the discretion of
the investigator).

- The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod
performance status 0-1 and weight loss >10% are considered eligible. In addition,
patients determined to be medically unfit or refusing combined modality therapy are
eligible.

- Age ≥ 18.

- Patients must have measurable or evaluable disease.

- Women of childbearing potential and male participants must agree to use an effective
method of contraception.

- Patients must sign study specific informed consent prior to study entry.

- Patients must not have plans for concurrent chemoradiation therapy.

- Patients must complete all required pretreatment evaluations

Exclusion Criteria:

- Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)

- Prior radiotherapy to the region of the study cancer that would result in direct
overlap of radiation therapy fields.

- Chemotherapy given within one week of study registration.

- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
or fetus.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III NSCLC in patients with poor performance status

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Robert Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

STU 052011-093

NCT ID:

NCT01459497

Start Date:

October 2012

Completion Date:

December 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • Stages II or III non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas Southwestern Medical CenterDallas, Texas