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Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

NCT00452803 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2010-07-12

No results posted yet for this study

Summary

It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.

Conditions

Interventions

DRUG

chemotherapy

Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

DRUG

Concurrent chemoradiation therapy

Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)

RADIATION

Concurrent chemoradiation therapy

Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Heung Tae Kim, 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
2006-04-30
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • South Korea

Study Locations

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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 NCT00452803 on ClinicalTrials.gov