MedTrace Logo

Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy

NCT00497250 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2008-10-21

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the tolerability and the maximum tolerated dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy.

Secondary objectives of the study are to obtain the preliminary information on efficacy after concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria.

To determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Gefitinib

gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT.

DEVICE

Radiation Therapy

group 1.54Gy/27Fx concurrent with gefitinib group 2.56Gy/28Fx concurrent with gefitinib group 3.58Gy/29Fx concurrent with gefitinib group 4.60Gy/30Fx concurrent with gefitinib

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Guoliang Jiang, MD · Fudan University Cancer Hospital, Department of Radiation Oncology

  • Min Fan, M.D. · Fudan University Cancer Hospital, Department of Radiation Oncology

  • Xiaolong Fu, M.D · Fudan University Cancer Hospital, Department of Radiation Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-03-31
Completion
2009-10-31

Countries

  • China

Study Locations

More Related Trials

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 NCT00497250 on ClinicalTrials.gov