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Completed

NCT Number: NCT00321334

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese Society of Lung Cancer

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy+Surgery

Procedure

Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles

Primary outcomes

  1. 3 years Disease Free Survival (at end of 3 years)

    Time frame: Prospective

Secondary outcomes

  1. 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)

    Time frame: Prospective

Sponsors and collaborators

Lead sponsor

Chinese Society of Lung Cancer

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
May 3, 2006
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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