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RTOG 0538/CALGB 30610

Status:

Recruiting | Phase III

Official Title:

Phase III Comparison Of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin Or Carboplatin And Etoposide

Study Purpose:

To determine if high dose radiotherapy given over a shorter period of time (3 weeks) is more effective than standard dose given over 7 weeks.

Interventions:

  • Study agents: Carboplatin or Cisplatin and Etoposide
  • Quality of Life questionnaires
  • ARM A: Radiotherapy is given twice a day every day for a total of 3 weeks. Carboplatiin or Cisplatin is given IV once every 21 days for a total of 4 times. Etoposide is given IV on days 1, 2 and 3 every 21 days for a total of 4 times.
  • ARM B: Radiotherapy is given every day once a day for a total of 7 weeks. Carboplatiin or Cisplatin is given IV once every 21 days for a total of 4 times. Etoposide is given IV on days 1, 2 and 3 every 21 days for a total of 4 times.

CT scans are performed after every 2 cycles and every 3 months for 2 years, every 6 months for 3 years and every year until year 10.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Histologically or cytologically documented small cell lung cancer determined to be limited stage small cell lung cancer.

Eligibility:

Limited stage disease patients.

Adequate lab work.

ECOG performance status 0 to 2.

Must have measurable disease by CT scan.

Non-pregnant or nursing.

No prior chemotherapy or radiotherapy for SCLC apart from 1 cycle of chemotherapy consisting of carboplatin or cisplatin and etoposide.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

RTOG 0538/CALGB 30610

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!