Clinical trial NCT00431613: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Induction chemotherapy
Concurrent chemoradiotherapy
Consolidation therapy
Docetaxel
Gemcitabine
Carboplatin
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Time to tumor progression (TTP)
timeFrame: 1 year
Secondary outcomes:
measure: Response rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
measure: Overall survival
timeFrame: Probability of 1-year survival (%)
measure: Toxicity
timeFrame: Toxicity assessment on each chemotherapy cycle
measure: Quality of life
timeFrame: Assessment every two cycles
measure: Symptom improvement
timeFrame: Assessment every two cycles
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
city: Athens
country: Greece
facility: Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
city: Piraeus
country: Greece
facility: Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: