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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)

This study has been withdrawn prior to enrollment.
(Poor Accrual)
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00431613
First received: February 5, 2007
Last updated: December 14, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin
Radiation: Chemoradiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time to tumor progression (TTP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Probability of 1-year survival (%) ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Symptom improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 208
Study Start Date: March 2006
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DG -> RT
Drug: Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Other Name: Taxotere
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Other Name: 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

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

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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431613

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
Air Forces Military Hospital, Dep of Medical Oncology
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
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, Greece
Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
Athens, Greece
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete
  More Information

No publications provided

Responsible Party: V.Georgoulias, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00431613     History of Changes
Other Study ID Numbers: CT/04.26
Study First Received: February 5, 2007
Last Updated: December 14, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
NSCLC
Induction chemotherapy
Concurrent chemoradiotherapy
Consolidation therapy
Docetaxel
Gemcitabine
Carboplatin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014