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Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

NCT00431613 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2015-05-29

No results posted yet for this study

Summary

The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Docetaxel

Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles

DRUG

Gemcitabine

Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles

DRUG

Carboplatin

Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles

RADIATION

Chemoradiotherapy

After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy. During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32

DRUG

Docetaxel

Docetaxel 75mg/m2 IV on day 1 for 3 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Vassilis Georgoulias, MD · University Hospital of Crete

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

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 NCT00431613 on ClinicalTrials.gov