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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


Phase 4
18 Years
80 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Description:

From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Di Zheng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Pulmonary Hospital, Shanghai, China

Authority:

China:Shanghai Pulmonary Hospital

Study ID:

SHPH-11ZL113

NCT ID:

NCT01336192

Start Date:

April 2011

Completion Date:

April 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Advanced NSCLC
  • Maintenance therapy
  • Gemcitabine
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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