CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
Cisplatin +3 moredrug
Likely dose
Cisplatin 50 mg/m² days 1, 8, 29, 36; Etoposide 50 mg/m² days 1-5, 29-33; Radiation 5940 cGy (180 cGy/day); Docetaxel 75 mg/m² IV every 3 weeks x 3 cycles (consolidation)AI-extracted
Key inclusion· 5
  • Histologic or cytologic evidence of NSCLC with unresectable Stage IIIA (N2) or Stage IIIB disease
  • N2 disease documented by biopsy, FDG-PET, or CT (nodes >2 cm)
  • Stage IIIB requires N3 or T4 status, with N3 documented by biopsy, FDG-PET, or CT (nodes >2 cm)
  • Measurable or evaluable disease on CT, MRI, X-ray, or physical exam within 28 days prior to treatment
Key exclusion· 6
  • Prior chemotherapy or radiotherapy for lung cancer
  • Unintended weight loss >5% body weight in preceding 3 months
  • Symptomatic peripheral neuropathy or neuropathy ≥Grade 2
  • Prior malignancy except adequately treated skin cancer, in situ cervical cancer, or disease-free >5 years

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

Search/NCT00216125
NCT00216125Phase 3Completed

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN01-24

Nasser Hanna, M.D.·interventional·Posted Sep 22, 2005·Updated Mar 16, 2016

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Etoposide, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 243 participants across 15 sites.

Detailed Summary

In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC. This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Study Details

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

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartFeb 1, 2002
Primary CompletionJun 1, 2006
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Cisplatindrug

Cisplatin 50 mg/m2 day 1, 8, 29, 36

Etoposidedrug

Etoposide 50 mg/m2, days 1-5, 29-33

Radiationradiation

Radiation 5940 cGy (180 cGy/day)

Docetaxeldrug

docetaxel 75mg/m2 q3wk x 3 cycles