CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 356 enrolled
Drug / intervention
Radiation therapy +1 moreradiation
Likely dose
PCI 30 Gy total dose (2 Gy per fraction, 5 days per week for 3 weeks)AI-extracted
Key inclusion· 7
  • Diagnosis of stage IIIA or IIIB non-small cell lung cancer
  • Complete response, partial response, or stable disease after definitive locoregional therapy (surgery and/or radiation, with or without chemotherapy)
  • No more than 16 weeks since prior therapy
  • No progressive disease
Key exclusion· 6
  • Other malignancy within the past 3 years (except nonmelanoma skin cancer)
  • Pregnant or nursing
  • Prior cranial irradiation
  • Concurrent anticancer biologic therapy

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

Search/NCT00048997
NCT00048997Phase 3Completed

A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer

Radiation Therapy Oncology Group·interventional·Posted Jan 27, 2003·Updated Jun 8, 2018

In Brief

A Phase 3 clinical trial evaluating Radiation therapy and Observation for Lung Cancer. Completed, enrolled 356 participants across 14 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2002
Primary CompletionDec 1, 2008
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 23.4 years ago

Interventions

Radiation therapyradiation

PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.

Observationother