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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431613

Enrollment

Registered

2007-02-06

Start date

2006-03-31

Completion date

2009-02-28

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

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

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

Interventions

DRUGDocetaxel

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

DRUGGemcitabine

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

DRUGCarboplatin

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

RADIATIONChemoradiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to tumor progression (TTP)	1 year

Secondary

Measure	Time frame
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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026