CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 224 enrolled
Drug / intervention
surgery +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 6
  • Suspicious lung nodule for clinical stage I NSCLC, ≤3 cm maximum diameter (clinical stage Ia or selected Ib with visceral pleural involvement)
  • ECOG performance status 0, 1, or 2
  • Meet at least one major criterion (FEV1 ≤50% predicted OR DLCO ≤50% predicted) OR minimum two minor criteria
  • CT chest with upper abdomen within 60 days prior to pre-registration
Key exclusion· 2
  • Prior intra-thoracic radiation therapy
  • Prior invasive malignancy, unless disease-free ≥5 years (exceptions: non-melanoma skin cancer, in-situ cancers)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00107172
NCT00107172Phase 3Completed

A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 6, 2005·Updated Oct 18, 2019

In Brief

A Phase 3 clinical trial evaluating surgery and brachytherapy for Lung Cancer. Completed, enrolled 224 participants across 38 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2005
Enrollment StartJul 1, 2005
Primary CompletionApr 18, 2013
Study CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 21.2 years ago

Interventions

surgeryprocedure

brachytherapyradiation