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

Qingdao University

Status and phase: Unknown; Phase 3

Conditions: Progression Free Survival

Treatments: Drug: cisplatin, etoposide, apatinib; Drug: cisplatin, etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT03100955

QU20170327

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

EP chemotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: cisplatin, etoposide

EP chemotherapy plus apatinib

Experimental group

Description:

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.

Treatment:

Drug: cisplatin, etoposide, apatinib