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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)

Primary Purpose

Non Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Gemcitabine
Carboplatin
Chemoradiotherapy
Docetaxel
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, Induction chemotherapy, Concurrent chemoradiotherapy, Consolidation therapy, Docetaxel, Gemcitabine, Carboplatin

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

DG -> RT

DG -> RT -> DCarbo

Outcomes

Primary Outcome Measures

Time to tumor progression (TTP)

Secondary Outcome Measures

Response rate
Overall survival
Toxicity
Quality of life
Symptom improvement

Full Information

First Posted
February 5, 2007
Last Updated
May 28, 2015
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00431613
Brief Title
Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to Poor Accrual
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, Induction chemotherapy, Concurrent chemoradiotherapy, Consolidation therapy, Docetaxel, Gemcitabine, Carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DG -> RT
Arm Title
2
Arm Type
Experimental
Arm Description
DG -> RT -> DCarbo
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
Intervention Type
Radiation
Intervention Name(s)
Chemoradiotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75mg/m2 IV on day 1 for 3 cycles
Primary Outcome Measure Information:
Title
Time to tumor progression (TTP)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Title
Overall survival
Time Frame
Probability of 1-year survival (%)
Title
Toxicity
Time Frame
Toxicity assessment on each chemotherapy cycle
Title
Quality of life
Time Frame
Assessment every two cycles
Title
Symptom improvement
Time Frame
Assessment every two cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassilis Georgoulias, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
IASO General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
Theagenion Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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