Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00431613
- Lead Sponsor
- Hellenic Oncology Research Group
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Gemcitabine DG -\> RT 2 Gemcitabine DG -\> RT -\> DCarbo 2 Carboplatin DG -\> RT -\> DCarbo 2 Chemoradiotherapy DG -\> RT -\> DCarbo 1 Docetaxel DG -\> RT 1 Chemoradiotherapy DG -\> RT 2 Docetaxel DG -\> RT -\> DCarbo
- Primary Outcome Measures
Name Time Method Time to tumor progression (TTP) 1 year
- Secondary Outcome Measures
Name Time Method Response rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) Overall survival Probability of 1-year survival (%) Toxicity Toxicity assessment on each chemotherapy cycle Symptom improvement Assessment every two cycles Quality of life Assessment every two cycles
Trial Locations
- Locations (10)
University Hospital of Crete
🇬🇷Heraklion, Crete, 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
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
🇬🇷Piraeus, Greece
401 Military Hospital, Medical Oncology Unit
🇬🇷Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
🇬🇷Athens, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
Theagenion Anticancer Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece