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This study has been withdrawn prior to enrollment.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:
Hellenic Oncology Research Group
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
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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 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
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 | |
| Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | |
| Athens, Greece | |
| Air Forces Military Hospital, Dep of Medical Oncology | |
| Athens, Greece | |
| IASO General Hospital of Athens, 1st Dep of Medical Oncology | |
| Athens, Greece | |
| Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases | |
| Athens, Greece | |
| Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
| 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Carboplatin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013