CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
stereotactic body radiation therapyradiation
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • ✓Stage I or II disease: T1 N0 M0, or T2 (≤5 cm) N0 M0, or T3 (≤5 cm) N0 M0 (chest wall only)
  • ✓No primary tumor within or touching proximal bronchial tree (defined as 2 cm in all directions around carina and main/lobar bronchi)
  • ✓Medically inoperable based on pulmonary function: FEV1 <40% predicted, or postoperative predicted FEV1 <30%, or severely reduced diffusion capacity, or baseline hypoxemia/hypercapnia, or exercise oxygen consumption <50% predicted, or severe pulmonary hypertension
Key exclusion· 7
  • ✕Primary T3 tumors involving central chest (≤2 cm toward carina) or mediastinal structures
  • ✕Hilar or mediastinal lymph nodes >1 cm on CT or suspicious on PET must be biopsied and confirmed negative
  • ✕Prior lung or mediastinal radiotherapy
  • ✕Concurrent chemotherapy, biologic therapy, vaccine therapy, standard fractionated radiotherapy, intensity modulated radiotherapy, or cobalt-60/charged particle beams

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

Search/NCT00087438
NCT00087438Phase 2Completed
CompareCT.gov

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer

Radiation Therapy Oncology Group·interventional·Posted Jul 12, 2004·Updated Jan 16, 2019

In Brief

A Phase 2 clinical trial evaluating stereotactic body radiation therapy for Lung Cancer. Completed, enrolled 59 participants across 2 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartMay 1, 2004
Primary CompletionMar 1, 2010
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 22.0 years ago

Interventions

stereotactic body radiation therapyradiation