Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000202561
Ethics application status
Approved
Date submitted
1/05/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
CSLC0501
Scientific title
A randomised controlled trial of Docetaxel plus Carboplatin as neo-adjuvant versus adjuvant chemotherapy treatment in stage IB to IIIA non-small cell lung cancer (NSCLC) to improve disease free survival
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 1180 0
Condition category
Condition code
Cancer 1263 1263 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with operable stage IB to IIIA NSCLC were randomised either to radical resection followed by three cycles of TP (Arm A) or three cycles of TP followed by radical resection (Arm B). Arm A: post-operative chemotherapy(adjuvant) Arm B: pre-operative chemotherapy(neo-adjuvant)TP regimen: Docetaxel: 75 mg/m², day 1 intravenous for1 hour, Carboplatin : AUC 5 , day 1 intravenous for 1 hour, Treatment is repeated every 3 weeks for a total of 3 cycles. All randomised patients who do not receive resection will be recommended to receive relevant treatment in line with National Comprehensive Cancer Network (NCCN) guideline.
Intervention code [1] 1009 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1701 0
3 years Disease Free Survival
Timepoint [1] 1701 0
At the end of 3 years
Secondary outcome [1] 3052 0
3 years Overall Survival rate
Timepoint [1] 3052 0
At end of 3 years
Secondary outcome [2] 3053 0
Safety data
Timepoint [2] 3053 0
After third cycle finish

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy; PS with ECOC 0-1; Adequate haematological and Hepatic- renal function; Expected live longer than 12monthes; The informed consent should be signed.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Small Cell Lung Cancer; Already receiving any prior anti-cancer treatment; Pregnant woman;With uncontrol diabetes, mental disease; Hepatic and renal function failure,The investigators believe the patients is not suitable to be enrolled in the study.

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)
Central randomisation by phone/FAX
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation with minimization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment outside Australia
Country [1] 305 0
China
State/province [1] 305 0

Funding & Sponsors
Funding source category [1] 1381 0
Charities/Societies/Foundations
Name [1] 1381 0
Chinese Society of Lung Cancer
Country [1] 1381 0
China
Funding source category [2] 1382 0
Hospital
Name [2] 1382 0
Guangdong Provincial People,s hospital
Country [2] 1382 0
China
Primary sponsor type
Charities/Societies/Foundations
Name
Chinese Society of Lung Cancer
Address
Country
China
Secondary sponsor category [1] 1217 0
None
Name [1] 1217 0
Nil
Address [1] 1217 0
Country [1] 1217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2733 0
Guangdong Provincial People's Hospital
Ethics committee address [1] 2733 0
Ethics committee country [1] 2733 0
China
Date submitted for ethics approval [1] 2733 0
Approval date [1] 2733 0
20/01/2006
Ethics approval number [1] 2733 0
GDPH[2006]3

Summary
Brief summary
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed worldwide. Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC. Based on proven activity and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting. The objective of the trial is to determine whether 3 cycles of TP after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36181 0
Address 36181 0
Country 36181 0
Phone 36181 0
Fax 36181 0
Email 36181 0
Contact person for public queries
Name 10198 0
Yi-long Wu
Address 10198 0
Guangdong Provincial People's Hospital
106 Zhongshan Er Road
Guangzhou 510080
Country 10198 0
China
Phone 10198 0
+86 20 83877855
Fax 10198 0
Email 10198 0
[email protected]
Contact person for scientific queries
Name 1126 0
Xiao-song Ben
Address 1126 0
Guangdong Provincial People's Hospital
106 Zhongshan Er Road
Guangzhou 510080
Country 1126 0
China
Phone 1126 0
+86 20 83877855
Fax 1126 0
Email 1126 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
No additional documents have been identified.