Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

NCT02039518 | Unknown Phase 2 DMC

• 1 other identifier: WXH-gemcitabine-SCLC
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy

Conditions

Small Cell Lung Cancer

Keywords

Progression free Survival

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (2)

gemcitabine

EXPERIMENTAL

gemcitabine 1000mg/m2，d1，d8，Q3W

Drug: gemcitabine

observation group

OTHER

observation

Other: observation group

Interventions

gemcitabine DRUG

gemcitabine 1000mg/m2，d1，d8，Q3W

Also known as: gemcitabine 1000mg/m2，d1，d8，Q3W

gemcitabine

observation group OTHER

observation group

observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• PS=0,1,2
• Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer
• Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD
• Expected lifetime\>12 weeks
• Signed written informed consent

You may not qualify if:

• Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of \>CTCAE caused tumor treatment past grade 2 toxicity Ccr\<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency：
• Tbil\> 1.5×ULN
• ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN)
• Severe symptomatic heart disease
• Symptomatic brain metastases
• In the last 5 years have been or are suffering from other histological types of malignant tumor
• There are serious or uncontrolled systemic diseases
• During the study period planned radiotherapy on target lesion
• During the study period, plans to use other antineoplastic therapy
• Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• WU X HUA, DOCTOR

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu X Hua, doctor

CONTACT

13482888167; xhwu2011@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 17, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

CN (1)