Non-small-cell Lung CancerPhase 3GECP-SCATNCT00478699

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

A Phase 3 study testing Docetaxel, Gemcitabine/Cisplatin and Docetaxel/Cisplatin in people with Non-small-cell Lung Cancer, run by Spanish Lung Cancer Group at 47 sites in Spain.

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 of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients. 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, Gemcitabine/Cisplatin and Docetaxel/Cisplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 47 sitesSpain
Study dates: Jun 2007to Jul 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with histological confirmation of non-small-cell lung carcinoma.
Complete surgical resection of the disease.
Tumoral tissue available for molecular analysis.
N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
Men or women age 18 years or older.
Patients with a performance status of 2 or less according to the ECOG classification.

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Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
Complete recovery from surgery within 6 weeks.
Patients who have given written informed consent before initiating any specific study screening procedure.

Who cannot join

Patients who have received previously chemotherapy or radiotherapy for the study disease.
Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
Women who are pregnant or in the period of lactation.
Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
Patients under treatment with investigational agents.

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

Spain47 sites

F.H.Alcorcon
Alcorcón, Madrid, 28922
H.G.U. Alicante
Alicante, 03010
Hospital de La Ribera
Alzira, Valencia, 46600
Ico - H. Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Univ. Sagrat Cor
Barcelona, 08036
Instituto Universitario Dexeus
Barcelona, 28036
Hospital de Basurto
Bilbao, Vizcaya
Hospital Provincial de Castellón
Castellon, Castellón
Hospital Reina Sofía
Córdoba, 14004
Hospital de Elche
Elche, Alicante, 03202
Ico-Girona (Hospital Josep Trueta)
Girona, 17007
Hospital Virgen de Las Nieves
Granada, 18015
Hospital de Jaén
Jaén, 23007
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, GRAN Canaria
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital de León
León
Hospital Arnau de Vilanova
Lleida, 46015
Hospital San Pedro
Logroño, La Rioja, 26004
Hospital 12 de Octubre
Madrid, 28006
Hospital Clínico San Carlos
Madrid, 28006
Hospital de La Princesa
Madrid, 28006
Md Anderson Internacional
Madrid, 28033
Fundación Jiménez Díaz
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital Puerta de Hierro
Madrid, 28222
Hospital Carlos Haya
Málaga, 29010
Hospital D'Althaia
Manresa, Barcelona, 08243
Hospital de Mataró
Mataró, Barcelona, 08034
Hospital Morales Messeguer
Murcia, 30008
Hospital Central de Asturias
Oviedo, Principality of Asturias
Clínica Rotger
Palma de Mallorca, 07012
Hospital Son Dureta
Palma de Mallorca, 07014
Hospital Son Llátzer
Palma de Mallorca, 07198
Hospital Clinico de Salamanca
Salamanca, 37007
Hospital de Donostia
San Sebastián, 20014
Instituto Oncológico de San Sebastián
San Sebastián
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Clin. Univ. Santiago de Compostela
Santiago de Compostela, LA Coruna, 15076
H. Arnau de Vilanova
Valencia, 46015
Hospital General de Valencia
Valencia
Instituto Valenciano de Oncología
Valencia
Hospital Provincial de Zamora
Zamora, 49012
Hospital Lozano Blesa
Zaragoza
Hospital Miguel Servet
Zaragoza

Other trials in Spain

About this study

Official title: Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Read the detailed description

Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Conditions: Non-small-cell Lung Cancer
Being tested: Docetaxel/Cisplatin control, Docetaxel, Gemcitabine/Cisplatin, Docetaxel/Cisplatin
Keywords: SCAT, BRCA1, BRCA1 mRNA Levels, ADJUVANT, LUNG, GECP-SCAT
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/Cisplatin controlDrug
Also called Taxotere/Platinol
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
DocetaxelDrug
Also called Taxotere
Docetaxel 75 mg/m2 day 1, 4 cycles
Gemcitabine/CisplatinDrug
Also called Gemzar/Platinol
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Docetaxel/CisplatinDrug
Also called Taxotere/Platinol
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Study groups in NCT00478699
Study group	Role	What they receive
1 Control group	Active comparator	Control group: *Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four. Receives: Drug: Docetaxel/Cisplatin control
2 Experimental group	Experimental	Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4. Receives: Drug: Docetaxel; Drug: Gemcitabine/Cisplatin; Drug: Docetaxel/Cisplatin

What is being measured

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

Estimated Overall Survival
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm).
Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.
Measured: 5 years

Secondary outcomes (1)

Disease Free Survival
To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.
Measured: 5 years

Timeline

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

Jun 2007Jul 2015

First posted25 May 2007 (estimated)
Study startJun 2007
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00478699
Sponsor's protocol ID: GECP-SCAT
Other IDs: 2007-000067-15
Acronym: GECP-SCAT
Status last verified: Oct 2024
First submitted: 24 May 2007
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients
ClinicalTrials.gov ID: NCT00478699
Acronym / sponsor ID: GECP-SCAT / GECP-SCAT
Conditions: Non-small-cell Lung Cancer
Keywords: SCAT, BRCA1, BRCA1 mRNA Levels, ADJUVANT, LUNG, GECP-SCAT
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Spanish Lung Cancer GroupUniversity, hospital or other
Study start: Jun 2007
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 May 2007 (estimated)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1 Control group	Active comparator	Drug: Docetaxel/Cisplatin controlControl group: *Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
2 Experimental group	Experimental	Drug: Docetaxel, Drug: Gemcitabine/Cisplatin, Drug: Docetaxel/CisplatinExperimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients with histological confirmation of non-small-cell lung carcinoma.
Complete surgical resection of the disease.
Tumoral tissue available for molecular analysis.
N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
Men or women age 18 years or older.

Key exclusion criteria (6 listed)

Patients who have received previously chemotherapy or radiotherapy for the study disease.
Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
Women who are pregnant or in the period of lactation.
Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Docetaxel/Cisplatin controlAlso: Taxotere/PlatinolDocetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles	Drug	1 Control group
DocetaxelAlso: TaxotereDocetaxel 75 mg/m2 day 1, 4 cycles	Drug	2 Experimental group
Gemcitabine/CisplatinAlso: Gemzar/PlatinolGemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles	Drug	2 Experimental group
Docetaxel/CisplatinAlso: Taxotere/PlatinolDocetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles	Drug	2 Experimental group

Primary outcome

Estimated Overall Survival
Time frame: 5 years
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.

1 secondary outcome

Disease Free Survival
Time frame: 5 years

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Arm	108	101
Experimental Arm	392	355

Primary outcome: Estimated Overall Survival

Time frame: 5 years. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Control Arm n = 101	Experimental Arm n = 355
Control arm vs Experimental arm	0.54 (0.44 to 0.64)	0.56 (0.51 to 0.61)
Control arm vs Gemcitabine /Cisplatin Experimental arm	0.54 (0.44 to 0.64)	0.56 (0.47 to 0.64)
Control arm vs Docetaxel /Cisplatin Experimental arm	0.54 (0.44 to 0.64)	0.53 (0.42 to 0.62)
Control arm vs Docetaxel Experimental Arm	0.54 (0.44 to 0.64)	0.60 (0.49 to 0.69)

Control Arm vs Experimental Arm: Hazard Ratio (HR): 0.946 (95% CI 0.689 to 1.298), p = 0.73, Log Rank

Population analysed: Only those patients validated by protocol. Patients not valid by protocol will be all those who, having given their informed consent do not receive the study treatment because of any reason and/or those patients who after treatment with chemotherapy do not have a minimum of six months of follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 70 month. Other adverse events reported at .4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	36 of 108 (33.3%)	105 of 108 (97.2%)	3 of 108
Experimental Group:All Reported Adverse Events Related to Study Medication	66 of 392 (16.8%)	384 of 392 (98%)	8 of 392

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Spanish Lung Cancer Group websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bartomeu Massutí Sureda, MD study chair

Hospital General Universitario de Alicante

Jose Miguel Sanchez Torres, MD study chair

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Gemcitabine/Cisplatin and Docetaxel/Cisplatin in people with Non-small-cell Lung Cancer, run by Spanish Lung Cancer Group at 47 sites in Spain.

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 9 inclusion and 6 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Estimated Overall Survival (time frame: 5 years). 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 NCT00478699.

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 12 Dec 2024.