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Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

NCT00030771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-01-17

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.

Conditions

Interventions

DRUG

Chemotherapy

Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days

RADIATION

Radiotherapy

Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

PROCEDURE

Surgery

3-4 weeks after termination of radiotherapy

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Miklos Pless, MD · Kantonsspital Winterthur KSW

  • Hans-Beat Ris, MD · Centre Hospitalier Universitaire Vaudois

  • Diana Naehrig, MD · Universitaetsspital-Basel

  • Roger Stupp, MD · Centre Hospitalier Universitaire Vaudoise

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2001-04-04
Primary Completion
2014-04-09
Completion
2023-09-15

Countries

  • Germany
  • Serbia
  • Switzerland

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 NCT00030771 on ClinicalTrials.gov