CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 265 enrolled
Drug / intervention
Prophylactic cranial irradiation, 2.5 Gy fx +2 moreradiation
Likely dose
25 Gy in 10 fractions (2.5 Gy once daily), 36 Gy in 18 fractions (2.0 Gy once daily), or 36 Gy in 24 fractions (1.5 Gy twice daily) prophylactic cranial irradiationAI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically confirmed limited-stage (I-IIIB) small cell lung cancer confined to one hemithorax, without T4 disease (malignant pleural effusion) or N3 disease (contralateral involvement)
  • ✓Complete response achieved after induction chemotherapy with or without thoracic radiotherapy
  • ✓Normal brain imaging (CT or MRI) obtained within 1 month before study entry
  • ✓No radiographic evidence of ipsilateral lung metastases or malignant pleural effusion (minimal effusion on CT allowed if not visible on chest x-ray)
Key exclusion· 5
  • ✕Prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
  • ✕Epilepsy requiring permanent oral medication
  • ✕Other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • ✕Concurrent chemotherapy or other concurrent antitumor agents

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

Search/NCT00057746
NCT00057746Phase 2Completed
CompareCT.gov

A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

Radiation Therapy Oncology Group·interventional·Posted Apr 9, 2003·Updated May 25, 2016

In Brief

A Phase 2 clinical trial evaluating Prophylactic cranial irradiation, 2.5 Gy fx, Prophylactic cranial irradiation, 2.0 Gy fx, and 1 other intervention for Lung Cancer. Completed, enrolled 265 participants across 222 sites in 2 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartFeb 1, 2003
Primary CompletionMay 1, 2009
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 23.2 years ago

Interventions

Prophylactic cranial irradiation, 2.5 Gy fxradiation

Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy

Prophylactic cranial irradiation, 2.0 Gy fxradiation

Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy

Prophylactic cranial irradiation, 1.5 Gy fxradiation

Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy