Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00431613
• Other study ID #: CT/04.26
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

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