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Non Small Cell Lung CancerPhase 2NCT00431613

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

A Phase 2 study testing Docetaxel, Gemcitabine and Carboplatin in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Docetaxel, Gemcitabine and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
10 sitesGreece
Study dates
Mar 2006to Feb 2009
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 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Greece10 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

  • 401 Military Hospital, Medical Oncology Unit

    Athens

  • Air Forces Military Hospital, Dep of Medical Oncology

    Athens

  • IASO General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

    Athens

  • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

    Athens

  • Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases

    Athens

  • University Hospital of Crete

    Heraklion, Crete, 71110

  • Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

    Piraeus

  • Theagenion Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: 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

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.

Read the 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

Being tested
Docetaxel, Gemcitabine, Carboplatin, Chemoradiotherapy
Keywords
NSCLC, Induction chemotherapy, Concurrent chemoradiotherapy, Consolidation therapy, Docetaxel, Gemcitabine, Carboplatin
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.

  • DocetaxelDrug

    Also called Taxotere

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

  • GemcitabineDrug

    Also called Gemzar

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

  • CarboplatinDrug

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

  • ChemoradiotherapyRadiation

    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

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 75mg/m2 IV on day 1 for 3 cycles

Study groups in NCT00431613
Study groupRoleWhat they receive
1ExperimentalDG -> RT
Receives: Drug: Docetaxel; Drug: Gemcitabine; Radiation: Chemoradiotherapy
2ExperimentalDG -> RT -> DCarbo
Receives: Drug: Docetaxel; Drug: Gemcitabine; Drug: Carboplatin; Radiation: Chemoradiotherapy

What is being measured

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

  1. Time to tumor progression (TTP)

    Measured: 1 year

Secondary outcomes (5)

  1. Response rate

    Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

  2. Overall survival

    Measured: Probability of 1-year survival (%)

  3. Toxicity

    Measured: Toxicity assessment on each chemotherapy cycle

  4. Quality of life

    Measured: Assessment every two cycles

  5. Symptom improvement

    Measured: Assessment every two cycles

Timeline

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

  1. First posted6 Feb 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Why it stopped: Due to Poor Accrual

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00431613
Sponsor's protocol ID
CT/04.26
Status last verified
May 2015
First submitted
5 Feb 2007
Last updated
29 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Gemcitabine and Carboplatin in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.

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 8 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: stopped early, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. 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 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 was stopped early (reason given: Due to Poor Accrual). Results are not available in the source record.

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?

Time to tumor progression (TTP) (time frame: 1 year). 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 NCT00431613.

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 29 May 2015.

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