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
Recruitment status was Recruiting
Sponsor:
Tongji University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 |
| 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
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
No publications provided
| 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013