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

NCT01459497 | Completed Phase 3 Results DMC

• 1 other identifier: STU 052011-093
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

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).

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Stages II or III non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival of Standard Radiation (CFRT) Versus Accelerated, Hypofractionated, Image-guided Conformal Radiotherapy (IGRT) in Treatment of Stage II-III NSCLC in Patients With Poor Performance Status at 1 Year.

  Percentage of participants with overall survival at 1 year. To compare the efficacy by overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III or recurrent NSCLC in patients with poor performance status. Overall survival time will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in survival distributions. The Cox proportional hazard regression model will be used to determine hazard ratios and 95% confidence intervals for the treatment difference in overall survival. Unadjusted ratios and ratios adjusted for stratification variables and other covariates of interest will be computed.

  1 year

Secondary Outcomes (7)

• Toxicities of Two Radiotherapy Treatment Regimens in Patients With Stage II-III Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

  60 months

• Time to Local Progression of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status

  60 months

• Disease-free Survival of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status.

  60 months

• Quality of Life of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status.

  6 months

• Cost Effectiveness of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status.

  2 years

Study Arms (2)

Radiation Therapy

ACTIVE COMPARATOR

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

Radiation: Radiation Therapy

Conventional Radiation

ACTIVE COMPARATOR

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

Radiation: Conventional radiation

Interventions

Radiation Therapy RADIATION

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

Radiation Therapy

Conventional radiation RADIATION

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

Conventional Radiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (7)

Georgetown Cancer Center (Austin Cancer Center)

Austin, Texas, 78758, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Baylor Research Institute Dallas, Baylor Irving

Irving, Texas, 75061, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Scott & White Memorial Temple

Temple, Texas, 76508, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Related Publications (1)

• 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.

  PMID: 34383006 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Our study has several limitations. First, it was closed to accrual before the enrollment goal was attained due to futility in reaching the primary endpoint; consequently, the lower than anticipated number of participants limited our multivariate analysis. Second, more than half of the patients were from a single site (University of Texas Southwestern). Finally, the outcomes may have differed in an immuno-therapy setting.

Results Point of Contact

• Title: Dr. Puneeth Iyengar
• Organization: University of Texas Southwestern Medical Center

puneeth.iyengar@utsouthwestern.edu

214-645-7603

Study Officials

• Puneeth Iyengar, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Puneeth Iyengar, MD

  puneeth.iyengar@utsouthwestern.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice Chair of Clinical Research

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2012
• Primary Completion: July 11, 2019
• Study Completion: October 19, 2023
• Last Updated: January 17, 2024
• Results First Posted: May 16, 2022

Record last verified: 2024-01

Locations

US (7)