Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer

Last updated: January 12, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Conventional radiation

Radiation Therapy

Clinical Study ID

NCT01459497
STU 052011-093
  • Ages 18-99
  • All Genders

Study Summary

The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients must be willing and capable to provide informed consent to participate inthe protocol.
  • Patients must have appropriate staging studies identifying them as AJCC stage II orIII non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendixIII), or recurrent non small cell lung cancer. Histologic confirmation of cancer willbe required by biopsy or cytology within 6 months of study entry.
  • Patients must have the potential for benefit from local therapy (at the discretion ofthe investigator).
  • The patient's Zubrod performance status must be 2 or greater OR patients with Zubrodperformance status 0-1 and weight loss >10% are considered eligible. In addition,patients determined to be medically unfit or refusing combined modality therapy areeligible.
  • Age ≥ 18.
  • Patients must have measurable or evaluable disease.
  • Women of childbearing potential and male participants must agree to use an effectivemethod 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

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 directoverlap of radiation therapy fields.
  • Chemotherapy given within one week of study registration.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryoor fetus.

Study Design

Total Participants: 103
Treatment Group(s): 2
Primary Treatment: Conventional radiation
Phase: 3
Study Start date:
October 01, 2012
Estimated Completion Date:
October 19, 2023

Study Description

The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction). Poor performance status patients can be a heterogeneous group, with tumor-related factors, other co-morbidities, or advanced age placing patients in the category. These patients have traditionally been underrepresented in clinical trials, and thus no prospective study has evaluated the efficacy of other radiotherapy dose fractionations in these patients. One phase III trial of "poor-risk" locally advanced NSCLC (RTOG 93-04) included just over 40% Karnofsky performance status 60-70 patients and showed median survival times of 9.5 and 10.3 months with 60Gy of conventional radiation therapy alone or with recombinant β-interferon [18]. 1 year overall survival was just 44% in these patients.

This study includes randomization to two arms. Arm A (experimental arm) will include IGRT, 60 Gy in 15 fractions (3 weeks). Arm B will include conventional radiation, 60-66 Gy in 30-33 fractions (6 weeks) with optional concurrent with carboplatin/taxol .

The experimental arm dose for this trial is based on a dose escalation trial at University of Texas Southwestern evaluating the maximum tolerated dose of hypofractionated IGRT in this patient population (Phase I study IRB #072010-050). Doses were escalated from 3 Gy per fraction (total dose 45 Gy) to 4 Gy per fraction (total dose 60 Gy) and evaluation for treatment related toxicity was being performed. Critical structure dose constraints will be expressed as organ dose-volume limits, with limits formulated with the approval of the study investigators using known tolerance data, radiobiological conversion models, and norms used in current practice at academic centers [27].

Randomization Schema:

Patients will be allocated to the treatment using a randomized permuted block within strata to balance for patient factors other than institution. The stratifying variables are Zubrod performance status (2 vs. > 2) and stage (II vs. III).

Connect with a study center

  • Georgetown Cancer Center (Austin Cancer Center)

    Austin, Texas 78758
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Research Institute Dallas, Baylor Irving

    Irving, Texas 75061
    United States

    Site Not Available

  • Texas Oncology - Sherman

    Sherman, Texas 75090
    United States

    Site Not Available

  • Scott & White Memorial Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

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