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

May 28, 2015 updated by: Hellenic Oncology Research Group

Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital, Medical Oncology Unit
      • Athens, Greece
        • Air Forces Military Hospital, Dep of Medical Oncology
      • Athens, Greece
        • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
      • Athens, Greece
        • IASO General Hospital of Athens, 1st Dep of Medical Oncology
      • Athens, Greece
        • Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
      • Piraeus, Greece
        • Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
      • Thessaloniki, Greece
        • Theagenion Anticancer Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC
  • no previous therapy for NSCLC is allowed
  • age >18 years
  • bidimensionally measurable disease
  • performance status (WHO) 0-2
  • absence of pleural effusion
  • adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • life expectancy of more than 3 months
  • written informed consent

Exclusion Criteria:

  • active infection
  • history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • malnutrition (loss of ≥ 20% of the original body weight)
  • performance status: 3-4
  • sensor or motor neuropathy > grade I
  • second primary malignancy, except for non-melanoma skin cancer
  • psychiatric illness or social situation that would preclude study compliance
  • pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
DG -> RT
Drug: Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Other Names:
  • Taxotere
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Other Names:
  • Gemzar
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
Other Names:
  • Taxotere
Experimental: 2
DG -> RT -> DCarbo
Drug: Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Other Names:
  • Taxotere
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Other Names:
  • Gemzar
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
Other Names:
  • Taxotere
Drug: Carboplatin
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression (TTP)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle
Quality of life
Time Frame: Assessment every two cycles
Assessment every two cycles
Response rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall survival
Time Frame: Probability of 1-year survival (%)
Probability of 1-year survival (%)
Symptom improvement
Time Frame: Assessment every two cycles
Assessment every two cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Vassilis Georgoulias, MD, University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/04.26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on Docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe