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Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III

NCT00620269 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2011-11-07

No results posted yet for this study

Summary

The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Conditions

Interventions

DRUG

Erlotinib

Erlotinib 150 mg p.o. daily x21 days every 3 weeks

DRUG

Induction or consolidation IP chemotherapy

Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles

DRUG

CCRT with IP chemotherapy (Irinotecan + Cisplatin)

Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

RADIATION

CCRT

CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jin Soo Lee, M.D. · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

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 NCT00620269 on ClinicalTrials.gov