None listed
Conditions
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.
Interventions
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)
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.
Sponsors
Chinese Society of Lung Cancer
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed