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TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer

NCT00349219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2016-01-15

No results posted yet for this study

Summary

The purpose of this study is to compare first-line erlotinib followed at progression by second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).

Conditions

Interventions

DRUG

erlotinib

erlotinib 150 mg taken orally daily until disease progression

DRUG

cisplatin

cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy

DRUG

gemcitabine

gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line

DRUG

cisplatin

cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles

DRUG

gemcitabine

gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles

DRUG

erlotinib

erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)

Sponsors & Collaborators

  • San Giuseppe Moscati Hospital

    collaborator OTHER

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Cesare Gridelli, M.D. · S.G. Moscati Hospital, Avellino, Italy

  • Charles Butts, M.D. · University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada

  • Fortunato Ciardiello, M.D., Ph.D. · Second University of Naples, Italy; Chair Medical Oncology

  • Ronald Feld, M.D. · Princess Margaret Hospital, Divison of Medical Oncology, Toronto, Ontario, Canada

  • Ciro Gallo, M.D., Ph.D. · Second University of Naples, Italy; Chair Medical Statistics

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples, Italy; Director Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-12-31
Completion
2012-06-30

Countries

  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349219 on ClinicalTrials.gov