Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01054482
First received: January 21, 2010
Last updated: February 1, 2010
Last verified: January 2007

January 21, 2010
February 1, 2010
February 2007
January 2011   (final data collection date for primary outcome measure)
To estimate the time to recurrence [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054482 on ClinicalTrials.gov Archive Site
  • To assess the pathologic complete response rate and the complete resection rate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • To estimate toxicities [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer
A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Pre-operative chemotherapy
    Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
  • Other: Pre-operative concurrent chemoradiation therapy

    Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles).

    Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

  • Experimental: Pre-operative chemotherapy
    Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
    Intervention: Drug: Pre-operative chemotherapy
  • Active Comparator: Pre-operative concurrent chemoradiation therapy
    Intervention: Other: Pre-operative concurrent chemoradiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histopathologic diagnosis of non small-cell lung cancer
  • Clinical stage IIIA and/or IIIB without pleural effusion
  • ECOG functional status 0 or 1
  • No renal function alteration (GFR >50%)
  • No hepatic function alteration (ALT and AST less than 2 times its normal value)
  • Leucocytes more than 2,000/mcl
  • Hemoglobin more than 10mg/dL
  • Platelets more than 100,000/mcl

Exclusion Criteria:

  • Active uncontrolled infection.
  • Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
  • MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
  • Significant neurological or mental disorder.
  • Second primary malignancy.
  • Pregnant or nursing.
Both
18 Years to 85 Years
No
Contact: Jianxing He, MD, FACS +86-20-83337792 drjianxing.he@gmail.com
Contact: Daoyuan Wang, MD +86-20-83337792 ghealth2008@gmail.com
China
 
NCT01054482
FAHG20070218
Yes
The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College
The First Affiliated Hospital of Guangzhou Medical University
Not Provided
Principal Investigator: Jianxing He, MD, FACS The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP