Maintenance Gemcitabine in the Chinese Advanced Lung Cancer (MAGICAL)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Tongji University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Shanghai Pulmonary Hospital, Shanghai, China

Information provided by:

Tongji University

ClinicalTrials.gov Identifier:

NCT01336192

First received: April 7, 2011

Last updated: April 13, 2011

Last verified: April 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Gemcitabine Drug: Best supportive care	Phase 4


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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Tongji University:

Primary Outcome Measures:

Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause

Secondary Outcome Measures:

Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
From the start of maintenance therapy or BSC until the date of documented death from any cause
Response Rate [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: No ]
From the start of maintenance therapy or BSC until the date of documented progressive disease
Time to The Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
From the start of maintenance therapy or BSC until the date of documented progressive disease
Health Related Quality of Life [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: Yes ]
From the start of maintenance therapy or BSC until the date of documented progressive disease or the termination of study
Number of Participants with treatment-related grade III/IV adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
frequency and severity of adverse events and laboratory abnormalities


Estimated Enrollment:	240
Study Start Date:	April 2011
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Best supportive care Best supportive care
Experimental: Maintenance gemcitabine Maintenance therapy of gemcitabine alone	Drug: Gemcitabine Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD Drug: Best supportive care Best supportive care

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336192

Contacts


Contact: Haiping Zhang, MD	86-21-65115006 ext 3068	zhp7341@hotmail.com

Locations


China, Shanghai
Shanghai Pulmonary Hospital Medical Oncology Department	Recruiting
Shanghai, Shanghai, China, 200433
Contact: Ying Xu, MD 86-21-65115006 ext 1053 xuying2186@hotmail.com
Principal Investigator: Di Zheng, MD

Sponsors and Collaborators

Tongji University

Shanghai Pulmonary Hospital, Shanghai, China

Investigators


Principal Investigator:	Di Zheng, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Chair:	Wen Gao, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Jianfang Xu, MD	Shanghai Pulmonary Hosptial
Study Director:	Li Wang, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Meijun Lv, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Jian Ni, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Jie Zhang, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Bing Lu, MD	Shanghai Pulmonary Hospital, Shanghai, China
Study Director:	Ying Xu, MD	Shanghai Pulmonary Hospital, Shanghai, China

More Information


Responsible Party:	Di Zheng/MD, Shanghai Pulmonary Hospital
ClinicalTrials.gov Identifier:	NCT01336192 History of Changes
Other Study ID Numbers:	SHPH-11ZL113
Study First Received:	April 7, 2011
Last Updated:	April 13, 2011
Health Authority:	China:Shanghai Pulmonary Hospital

Keywords provided by Tongji University:


Advanced NSCLC Maintenance therapy Gemcitabine

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 Gemcitabine	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

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