Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321334
• Other study ID #: CSLC0501
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2006
• Last updated: August 4, 2014
• Start date: March 2006
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Chinese Society of Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.

Description:

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.

Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy;

• age from 18 to 75;

• PS with ECOC 0-1;

• Adequate haematological and Hepatic- renal function;

• Expected to live longer than 12 months;

• The informed consent should be signed.

Exclusion Criteria:

• Patients with Small Cell Lung Cancer;

• Already receiving any prior anti-cancer treatment;

• Pregnant women;

• Uncontrolled diabetes, mental disease;

• Hepatic and renal function failure;

• The investigators believe the patient is not suitable to be enrolled in the study

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• Chemotherapy+Surgery
Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles

Locations

Country	Name	City	State
China	Chinese Society of Lung Cancer	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Society of Lung Cancer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 years Disease Free Survival (at end of 3 years)		Prospective	Yes
Secondary	3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)		Prospective	Yes