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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01054482
• Other study ID #: FAHG20070218
• Status: Recruiting
• Phase: Phase 2
• First received: January 21, 2010
• Last updated: February 1, 2010
• Start date: February 2007
• Est. completion date: December 2011

Study information

• Verified date: January 2007
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing He, MD, FACS
• Phone: +86-20-83337792
• Email: drjianxing.he[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the time to recurrence		Every 3 months	No
Secondary	To assess the pathologic complete response rate and the complete resection rate		Every 4 weeks	No
Secondary	To estimate toxicities		Every 4 weeks	Yes