Radical Resection Vs. Ablative Stereotactic Radiotherapy in Patients With Operable Stage I NSCLC

NCT01753414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-01-06

Study results available
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Summary

Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. This technique may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery in treating non-small cell lung cancer.

Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of SBRT is comparable to that of standard surgical interventions for patients with T1N0 non-small cell lung cancer.

Conditions

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Daily fractions

PROCEDURE

Surgery

Radical resection

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY
  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Feng-Ming (Spring) Kong, MD, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2023-04-03
Completion
2026-01-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753414 on ClinicalTrials.gov