CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin 60 mg/m² IV on days 1, 22, 43, 64; Etoposide 120 mg/m² IV on days 1-3, 22-24, 43-45, 64-66; concurrent with thoracic radiation 28.8 Gy (1.8 Gy per fraction, 5 days/week for 16 fractions with BID boost days 23-26 and off-cord boost last 5 days)AI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed small cell carcinoma of the lung
  • Limited disease: Stage I, II, IIIA, or IIIB confined to one hemithorax (excluding T4 with malignant pleural effusion or N3 contralateral disease)
  • Measurable or evaluable disease
  • Tumor must be encompassable by limited radiotherapy fields without significantly compromising pulmonary function
Key exclusion· 7
  • No pericardial or pleural effusions on chest x-ray
  • Prior complete tumor resection
  • Prior chemotherapy
  • Prior radiotherapy to the chest or bone marrow-rich areas (>75% of pelvic bone)

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

Search/NCT00066222
NCT00066222Phase 2Completed

A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer

Radiation Therapy Oncology Group·interventional·Posted Aug 7, 2003·Updated Dec 22, 2017

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Etoposide, and 1 other intervention for Lung Cancer. Completed, enrolled 72 participants across 104 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartJun 1, 2003
Primary CompletionMay 1, 2012
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 22.9 years ago

Interventions

Cisplatindrug

60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.

Etoposidedrug

120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.

Radiation therapyradiation

Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.