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Non Small-cell Lung CancerPhase 2GECP0008NCT01652820

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

A Phase 2 study testing Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day and 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 in people with Non Small-cell Lung Cancer, run by Spanish Lung Cancer Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small-cell Lung Cancer
What is being tested?
Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day and 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
Oct 2001to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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

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

Being tested
Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day, 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
Keywords
LUNG, DOCETAXEL, GEMCITABINE, CARBOPLATIN, RADIOTHERAPY
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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/dDrug

Study groups in NCT01652820
Study groupRoleWhat they receive
Docetaxel +Carboplatin +concomitant chemoradiationExperimentalDocetaxel 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)
Receives: Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day; Drug: 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 concomExperimentalDocetaxel 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)
Receives: Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day; Drug: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From enrollment to first response assesment

Secondary outcomes (3)

  1. Local control rate at 1 year

    Measured: 1 year

  2. Time to progression

    Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)

    Measured: From enrollment to first progression date

  3. Overall Survival

    Arm B: 14.3 m and arm C: 14.7 m; p= 0.3

    Measured: From enrollment to last follow up or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2012 (estimated)
  2. Study startOct 2001
  3. Primary completionJul 2006
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01652820
Sponsor's protocol ID
GECP 00-08 / TAX.ES1.209
Acronym
GECP0008
Status last verified
May 2025
First submitted
17 Jul 2012
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23611405

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day and 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 in people with Non Small-cell Lung Cancer, run by Spanish Lung Cancer Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: From enrollment to first response assesment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652820, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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