Clinical trial NCT01336192: Maintenance Gemcitabine in the Chinese Advanced Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non Small Cell Lung Cancer
Keywords: Advanced NSCLC
Maintenance therapy
Gemcitabine
Lead sponsor: Tongji University
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2011-04-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 18 months
measure: Response Rate
timeFrame: approximately 4 weeks
measure: Time to The Progression
timeFrame: 18 months
measure: Health Related Quality of Life
timeFrame: Approximately 4 weeks
measure: Number of Participants with treatment-related grade III/IV adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital Medical Oncology Department
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Di Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Wen Gao, MD
role: STUDY_CHAIR
affiliation: Shanghai Pulmonary Hosptial
name: Jianfang Xu, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Li Wang, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Meijun Lv, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jian Ni, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jie Zhang, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Bing Lu, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Ying Xu, MD
role: STUDY_DIRECTOR
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