CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
Prophylactic Cranial Irradiation +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01055197
NCT01055197Phase 2Completed

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

Radiation Therapy Oncology Group·interventional·Posted Jan 25, 2010·Updated Dec 12, 2018

In Brief

A Phase 2 clinical trial evaluating Prophylactic Cranial Irradiation and Radiation Therapy for Lung Cancer. Completed, enrolled 97 participants across 115 sites in 3 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer. PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 16.4 years ago

Interventions

Prophylactic Cranial Irradiationradiation

Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.

Radiation Therapyradiation

Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy