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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054482
First Posted: January 22, 2010
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Pre-operative chemotherapy Other: Pre-operative concurrent chemoradiation therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • To estimate the time to recurrence [ Time Frame: Every 3 months ]

Secondary Outcome Measures:
  • To assess the pathologic complete response rate and the complete resection rate [ Time Frame: Every 4 weeks ]
  • To estimate toxicities [ Time Frame: Every 4 weeks ]

Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
Active Comparator: Pre-operative concurrent chemoradiation therapy 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


Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054482


Contacts
Contact: Jianxing He, MD, FACS +86-20-83337792 drjianxing.he@gmail.com
Contact: Daoyuan Wang, MD +86-20-83337792 ghealth2008@gmail.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Wenlong Shao, MD    +86-20-83337750 ext 7040    myfriends2003@126.com   
Contact: Daoyuan Wang, MD    +86-20-83337750 ext 7040    ghealth2008@gmail.com   
Principal Investigator: Jianxing He, MD, FACS         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Jianxing He, MD, FACS The First Affiliated Hospital of Guangzhou Medical University
  More Information

Responsible Party: The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College
ClinicalTrials.gov Identifier: NCT01054482     History of Changes
Other Study ID Numbers: FAHG20070218
First Submitted: January 21, 2010
First Posted: January 22, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2007

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Neoadjuvant chemotherapy
neoadjuvant chemoradiotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action