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Spots Global Cancer Trial Database for Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

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Trial Identification

Brief Title: 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 ID: NCT01336192

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Shanghai Pulmonary Hospital Medical Oncology Department, Shanghai, Shanghai, China

Contact Details

Name: Di Zheng, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: PRINCIPAL_INVESTIGATOR

Name: Wen Gao, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_CHAIR

Name: Jianfang Xu, MD

Affiliation: Shanghai Pulmonary Hosptial

Role: STUDY_DIRECTOR

Name: Li Wang, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Name: Meijun Lv, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Name: Jian Ni, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Name: Jie Zhang, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Name: Bing Lu, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Name: Ying Xu, MD

Affiliation: Shanghai Pulmonary Hospital, Shanghai, China

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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