Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01652820

Acronym

GECP0008

Enrollment

140

Registered

2012-07-30

Start date

2001-10-31

Completion date

2007-12-31

Last updated

2025-05-23

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

LUNG, DOCETAXEL, GEMCITABINE, CARBOPLATIN, RADIOTHERAPY

Brief summary

Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel

Interventions

DRUGDocetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

DRUGDocetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Unresectable stage IIIA or B NSCLC patients * WHO PS 0 or 1 * Weight loss \< 5 % within the last 3 months * At least one measurable lesion * Planning CT scan previous to randomization * Written informed consent

Exclusion criteria

* Malignant effusion, supraclavicular node or SVCS * PTV \> 2000 cm3 * V20 \> 35% * FEV1 and DLCO both \< 30% or 1 liter at study entry

Design outcomes

Primary

Measure	Time frame	Description
Overall response rate	From enrollment to first response assesment	The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing

Secondary

Measure	Time frame	Description
Local control rate at 1 year	1 year	—
Time to progression	From enrollment to first progression date	Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)
Overall Survival	From enrollment to last follow up or death	Arm B: 14.3 m and arm C: 14.7 m; p= 0.3

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026