Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— MAGICAL  

Official title:

Maintenance Gemcitabine or Best Supportive Care for the Chinese Advanced NSCLC Patients Without Progression Disease After Given Four Cycles of the Induction Chemotherapy With Gemcitabine Plus Cisplatin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01336192
• Other study ID #: SHPH-11ZL113
• Status: Recruiting
• Phase: Phase 4
• First received: April 7, 2011
• Last updated: April 13, 2011
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2011
• Source: Tongji University
• Contact: Haiping Zhang, MD
• Phone: 86-21-65115006
• Email: zhp7341[@]hotmail.com
• Is FDA regulated: No
• Health authority: China:Shanghai Pulmonary Hospital
• Study type: Interventional

Clinical Trial Summary

Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.

Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors.

• No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment.

• Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases.

• ECOG score 0-1

Exclusion Criteria:

• First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin

• Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment.

• Active infection

• Inadequate liver and renal function.

• Serious concomitant systemic disorder incompatible with the study.

• Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence)

• Presence of the pregnancy

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gemcitabine
Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD
• Best supportive care
Best supportive care

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital Medical Oncology Department	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Tongji University	Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause	12 months	No
Secondary	Overall Survival	From the start of maintenance therapy or BSC until the date of documented death from any cause	18 months	No
Secondary	Response Rate	From the start of maintenance therapy or BSC until the date of documented progressive disease	approximately 4 weeks	No
Secondary	Time to The Progression	From the start of maintenance therapy or BSC until the date of documented progressive disease	18 months	No
Secondary	Health Related Quality of Life	From the start of maintenance therapy or BSC until the date of documented progressive disease or the termination of study	Approximately 4 weeks	Yes
Secondary	Number of Participants with treatment-related grade III/IV adverse events	frequency and severity of adverse events and laboratory abnormalities	6 months	Yes