Clinical trial NCT00321334: Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
Official title: Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Chemotherapy
surgery
neo-adjuvant
adjuvant
RCT
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3 years Disease Free Survival (at end of 3 years)
timeFrame: Prospective
Secondary outcomes:
measure: 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)
timeFrame: Prospective
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Chinese Society of Lung Cancer
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yi-Long Wu, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: