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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00431613
Other study ID # CT/04.26
Secondary ID
Status Terminated
Phase Phase 2
First received February 5, 2007
Last updated May 28, 2015
Start date March 2006
Est. completion date February 2009

Study information

Verified date May 2015
Source Hellenic Oncology Research Group
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 38
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 75 Years
Eligibility 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

Study Design

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


Intervention

Drug:
Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Carboplatin
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
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

Locations

Country Name City State
Greece University General Hospital of Alexandroupolis, Dep of Medical Oncology Alexandroupolis
Greece 401 Military Hospital, Medical Oncology Unit Athens
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 University Hospital of Crete Heraklion Crete
Greece Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology Piraeus
Greece Theagenion Anticancer Hospital of Thessaloniki Thessaloniki

Sponsors (2)

Lead Sponsor Collaborator
Hellenic Oncology Research Group University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to tumor progression (TTP) 1 year No
Secondary Response rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) No
Secondary Overall survival Probability of 1-year survival (%) No
Secondary Toxicity Toxicity assessment on each chemotherapy cycle Yes
Secondary Quality of life Assessment every two cycles No
Secondary Symptom improvement Assessment every two cycles No
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