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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
University Hospital of Crete
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Time to tumor progression (TTP)
Time frame: 1 year
Response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall survival
Time frame: Probability of 1-year survival (%)
Toxicity
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life
Time frame: Assessment every two cycles
Symptom improvement
Time frame: Assessment every two cycles
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece