A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Progression Free Survival Clinical Trial

Official title:

A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100955
• Other study ID #: QU20170327
• Status: Recruiting
• Phase: Phase 3
• First received: March 26, 2017
• Last updated: March 29, 2017
• Start date: March 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2017
• Source: Qingdao University
• Contact: keke nie, MD
• Phone: (86)18561857907
• Email: niekekeqd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically verified SCLC, extensive stages

2. WHO performance status 0, 1, 2

3. Age 18 years or older

4. Treatment naive

5. Anticipated survival more than 3 months

6. HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L

7. No prognancy

8. Signed informed consent

Exclusion Criteria:

1. Limited stage disease

2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm

3. Uncontrolled hypertension

4. Uncontrolled heart failure

5. Coagulation problem

6. Surgery, trauma, uncontrolled ulcer in 4 weeks.

7. Required by physician

Related Conditions & MeSH terms

• Disease Progression
• Progression Free Survival
• Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatin, etoposide
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.
• cisplatin, etoposide, apatinib
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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	from the date of randomization to disease progression	24 months