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Trial registered on ANZCTR


Registration number
ACTRN12609000946213
Ethics application status
Approved
Date submitted
12/10/2009
Date registered
4/11/2009
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase III randomized study with Paclitaxel (Taxol) and Gemcitabine or Vinorelbine in patients with stage IIIBw - IV non-operable non-small cell lung cancer (NSCLC), performance status (PS) 0,1.
Scientific title
The comparative effect of combination chemotherapy with Paclitaxel (Taxol) and Gemcitabine vs Taxol and Vinorelbine on survival in non-operable non-small cell lung cancer stage IIIBw and IV, PS : 0, 1. A Phase III randomized study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 243622 0
Condition category
Condition code
Cancer 239921 239921 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GROUP B
Days 1, 8, 15
Taxol: 80mg/m2 in Normal Saline (N/S) 0.9% in 3h infusion followed premedication.
Vinorelbine : 22.5mg/m2 in 10 minute infusion followed by vein washing with normal saline.
Vinorelbine will be given first followed by Taxol.
Treatment will be repeated every 4 weeks for a total of 4 cycles
No growth factor routinely will be given and antiemetic h² blockers (H2-receptor antagonists) will be used accordingly .
Intervention code [1] 241211 0
Treatment: Drugs
Comparator / control treatment
GROUP A
Day 1
Taxol : 200 mg/m2 in Normal Saline (N/S) 0.9% as 3h infusion on day 1 with premedication.
Gemcitabine : 1000 mg/m2 in 500ml N/S as a 30min infusion.

Day 8
Gemcitabine : 1000 mg/m2 in 500ml N/S as a 30min infusion.
Treatment will be repeated every 3 weeks for a total of 4 cycles
No growth factor routinely will be given and antiemetic h² blockers will be used accordingly .
Control group
Active

Outcomes
Primary outcome [1] 253023 0
Survival
Timepoint [1] 253023 0
1 year.
This outcome is assessed using clinical data records
Secondary outcome [1] 257615 0
Response
Timepoint [1] 257615 0
Response is assessed after 3 cycles of chemotherapy by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.
Secondary outcome [2] 257898 0
Time to Progression (TTP)
Timepoint [2] 257898 0
After the end of treatment Progression is assessed every 3 months.
Secondary outcome [3] 257899 0
Time to Progression (TTP)
Timepoint [3] 257899 0
After the end of treatment Progression is assessed every 3 months.
Secondary outcome [4] 257900 0
Toxicity
Timepoint [4] 257900 0
Toxicity is assessed after each cycle by laboratory evaluation of hematology and biochemistry, physical examination etc.

Eligibility
Key inclusion criteria
Histologically proven inoperable or recurrent or metastatic NSCLC stage IIIBw and IV. Biopsy, fine needle aspiration or sputum cytology will be used to obtain the samples.
Performance status 0, 1 of the Eastern Cooperative Oncology Group (ECOG) scale .
Measurable disease outside prior radiotherapy ports required , unless subsequent progression is documented .
Stable brain metastases .
Prior surgery or radiotherapy is allowed .
Age > 18 years .
Life expectancy at least 12 weeks.
White Blood Cells (WBC) > 4.000/ml or platelets > 100.000/ml, Bilirubin < 1.2 mg/dl, gamma-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, serum creatinine < 1.4 mg/dl and creatinine clearance > 60 ml/min.
Informed consent has to be signed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past or current history of neoplasm, except for Basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Previous treatment with chemotherapy for recurrent or metastatic disease.
History of atrial or ventricular arrhythmias, congestive heart failure even if medically controlled. Documented myocardial infarction.
Pre – existing motor or sensory neurotoxicity grade >2 according to World Health Organisation (WHO) scale (intolerable paresthesias and/or marked motor loss , or worse).
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment .

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
441
Accrual to date
Final
Recruitment outside Australia
Country [1] 1975 0
Greece
State/province [1] 1975 0

Funding & Sponsors
Funding source category [1] 237570 0
Other Collaborative groups
Name [1] 237570 0
Hellenic Cooperative Oncology Group
Country [1] 237570 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524 Athens
Country
Greece
Secondary sponsor category [1] 237045 0
None
Name [1] 237045 0
Address [1] 237045 0
Country [1] 237045 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a prospective randomized phase III study comparing Paclitaxel and Gemcitabine with Paclitaxel and Vinorelbine in the treatment of patients with advanced non – operable non-small cell lung cancer (NSCLC).
Patients are randomized into two groups: Group A receive Gemcitabine on days 1 and 8 and Paclitaxel on day 1, every 3 weeks.
Group B receive: Paclitaxel and Vinorelbine on days 1, 8, 15 every 4 weeks.
Both regimens will be given for 4 cycles.
The following parameters will be evaluated:
Survival, Time to progression, Response rates, Toxicity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30111 0
Address 30111 0
Country 30111 0
Phone 30111 0
Fax 30111 0
Email 30111 0
Contact person for public queries
Name 13358 0
Eleni Papakostaki
Address 13358 0
Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524, Athens
Country 13358 0
Greece
Phone 13358 0
+302106912520
Fax 13358 0
+302106912713
Email 13358 0
[email protected]; [email protected]
Contact person for scientific queries
Name 4286 0
Paris Kosmidis
Address 4286 0
2nd Department of Medical Oncology, Hygeia Hospital, Kifisias Av & Er. Stavrou 4, 15123 Athens
Country 4286 0
Greece
Phone 4286 0
+302106867105
Fax 4286 0
Email 4286 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPaclitaxel and gemcitabine versus paclitaxel and vinorelbine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group (HeCOG)2010https://doi.org/10.1093/annonc/mdq445
N.B. These documents automatically identified may not have been verified by the study sponsor.