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

NCT ID: NCT01459497

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2023-10-19

Brief 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).

Detailed 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).

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy

Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks

Conventional Radiation

Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks

Group Type: ACTIVE_COMPARATOR

Conventional radiation

Intervention Type: RADIATION

Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks

Interventions

Radiation Therapy

Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks

Intervention Type: RADIATION

Conventional radiation

Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Puneeth Iyengar

Associate Vice Chair of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Puneeth Iyengar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Puneeth Iyengar, MD

Role: PRINCIPAL_INVESTIGATOR

puneeth.iyengar@utsouthwestern.edu

Locations

Georgetown Cancer Center (Austin Cancer Center)

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Md Anderson Cancer Center

Houston, Texas, United States

Baylor Research Institute Dallas, Baylor Irving

Irving, Texas, United States

Texas Oncology - Sherman

Sherman, Texas, United States

Scott & White Memorial Temple

Temple, Texas, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Countries

United States

References

Iyengar P, Zhang-Velten E, Court L, Westover K, Yan Y, Lin MH, Xiong Z, Patel M, Rivera D, Chang J, Saunders M, Shivnani A, Lee A, Hughes R, Gerber D, Dowell J, Gao A, Heinzerling J, Li Y, Ahn C, Choy H, Timmerman R. Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non-Small Cell Lung Cancer and Poor Performance Status: A Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1497-1505. doi: 10.1001/jamaoncol.2021.3186.

Reference Type: DERIVED

PMID: 34383006 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

STU 052011-093

Identifier Type: -

Identifier Source: org_study_id