NCT01652820

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

July 17, 2012

Last Update Submit

May 19, 2025

Conditions

Non Small-cell Lung Cancer

Keywords

LUNGDOCETAXELGEMCITABINECARBOPLATINRADIOTHERAPY

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing

    From enrollment to first response assesment

Secondary Outcomes (3)

  • Local control rate at 1 year

    1 year

  • Time to progression

    From enrollment to first progression date

  • Overall Survival

    From enrollment to last follow up or death

Study Arms (2)

Docetaxel +Carboplatin +concomitant chemoradiation

EXPERIMENTAL

Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)

Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/dayDrug: Docetaxel 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

C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom

EXPERIMENTAL

Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)

Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/dayDrug: Docetaxel 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

Interventions

Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/dayDRUG
C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concomDocetaxel +Carboplatin +concomitant chemoradiation
Docetaxel 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/dDRUG
C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concomDocetaxel +Carboplatin +concomitant chemoradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, Cardenal F, Arnaiz Mdel M, Moran T, Morera R, Isla D, Valencia J, Cobo M, Delgado R, Garcia-Gomez R, Calvo F, Zamora J, Ramos A, Massuti B. Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer. 2013 Jul;81(1):84-90. doi: 10.1016/j.lungcan.2013.03.009. Epub 2013 Apr 21.

    PMID: 23611405DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Pilar Garrido, MD

    Hospital Ramon y Cajal (Madrid)

    PRINCIPAL INVESTIGATOR

  • Rafael Rosell, MD

    Germans Trias i Pujol Hospital

    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

July 17, 2012

First Posted

July 30, 2012

Study Start

October 1, 2001

Primary Completion

July 1, 2006

Study Completion

December 1, 2007

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share