NCT03100955

Brief Summary

To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 26, 2017

Last Update Submit

March 29, 2017

Conditions

Progression Free Survival

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    from the date of randomization to disease progression

    24 months

Study Arms (2)

EP chemotherapy

ACTIVE COMPARATOR

Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide.

Drug: cisplatin, etoposide

EP chemotherapy plus apatinib

EXPERIMENTAL

Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib.

Drug: cisplatin, etoposide, apatinib

Interventions

cisplatin, etoposideDRUG

The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.

EP chemotherapy
cisplatin, etoposide, apatinibDRUG

Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.

EP chemotherapy plus apatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically verified SCLC, extensive stages
  • WHO performance status 0, 1, 2
  • Age 18 years or older
  • Treatment naive
  • Anticipated survival more than 3 months
  • HB \>90g/L, ANC\>1.5 x 109/L, Platelets \>80 x109 /L
  • No prognancy
  • Signed informed consent

You may not qualify if:

  • Limited stage disease
  • Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
  • Uncontrolled hypertension
  • Uncontrolled heart failure
  • Coagulation problem
  • Surgery, trauma, uncontrolled ulcer in 4 weeks.
  • Required by physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266001, China

RECRUITING

MeSH Terms

Interventions

PE regimenCisplatinEtoposideapatinib

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Zhuang Yu, MD, Ph. D

    The Affiliated Hospital of Qingdao University

    STUDY CHAIR

Central Study Contacts

keke nie, MD

CONTACT

(86)18561857907niekekeqd@163.com

youxin ji, MD, Ph. D

CONTACT

(86)532-68665078ji6677@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Secretary of clinical trials

Study Record Dates

First Submitted

March 26, 2017

First Posted

April 4, 2017

Study Start

March 1, 2017

Primary Completion

February 1, 2019

Study Completion

August 1, 2019

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)