CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Temozolomide 75 mg/m² daily for 14 days concurrent with whole brain radiotherapy (30 Gy in 10 fractions), followed by 200 mg/m² daily x 5 days (or 150 mg/m² if prior chemotherapy) every 28 days for 2 additional cyclesAI-extracted
Key inclusion· 8
  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • At least 1 bidimensionally measurable brain metastasis confirmed by MRI within past 2 weeks
  • Not eligible for surgical resection or radiosurgery of brain metastasis
  • Systemic disease not in immediate need of chemotherapy
Key exclusion· 7
  • HIV positive or AIDS-related illness
  • Prior temozolomide
  • Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
  • Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy

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

Search/NCT00080938
NCT00080938Phase 2Completed

A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)

Eastern Cooperative Oncology Group·interventional·Posted Apr 8, 2004·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Temozolomide and Radiation therapy for Lung Cancer and Metastatic Cancer. Completed, enrolled 26 participants.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2004
Enrollment StartDec 20, 2005
Primary CompletionAug 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 22.2 years ago

Interventions

Temozolomidedrug

Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles.

Radiation therapyradiation

Standard whole brain radiation therapy 30 Gy in ten fractions.