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

NCT00431613 | Terminated Phase 2

• 1 other identifier: CT/04.26
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 10

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; Induction chemotherapy; Concurrent chemoradiotherapy; Consolidation therapy; Docetaxel; Gemcitabine; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression (TTP)

  1 year

Secondary Outcomes (5)

• 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

• Quality of life

  Assessment every two cycles

• Symptom improvement

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

DG -\> RT

Drug: Docetaxel; Drug: Gemcitabine; Radiation: Chemoradiotherapy

2

EXPERIMENTAL

DG -\> RT -\> DCarbo

Drug: Docetaxel; Drug: Gemcitabine; Drug: Carboplatin; Radiation: Chemoradiotherapy

Interventions

Docetaxel DRUG

Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles

Also known as: Taxotere

1; 2

Gemcitabine DRUG

Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles

Also known as: Gemzar

1; 2

Carboplatin DRUG

Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles

2

Chemoradiotherapy RADIATION

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

1; 2

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Piraeus, Greece

Location

Theagenion Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Gemcitabine; Carboplatin; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 6, 2007
• Study Start: March 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

GR (10)