Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung Cancer

Small-cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Trial of Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin in Combination With Concurrent Thoracic Radiotherapy for Patients With Limited Small-cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613597
• Other study ID #: L-SCLC-001
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2020
• Source: Guizhou Medical University
• Contact: ShengFa Su, PhD,MD
• Phone: 0086-851-86513076
• Email: sushengfa2005[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (etoposide plus lobaplatin or etoposide plus cisplatin) in combination with concurrent thoracic radiation therapy (TRT) for limited stage small cell lung cancer.

Description:

Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models. A randomized, multicenter phase III study showed that Lobaplatin plus etoposide (EL) regimen is not inferiority to cisplatin plus etoposide (EP) regimen in terms of PFS, the tolerance and QOL with EL regimen are better than that with EP regimen. Thus, we perform this study was to compare the efficacy and safety of EL and EP regimens concurrently with thoracic radiotherapy in patients with limited-stage SCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed SCLC

• Newly diagnosed SCLC

• Either sex, age between 18 to 75 years

• Limited stage: AJCC (8th edition) Stage I-III (T any, N any, M0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.

• Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.

• Adequate bone marrow, liver and renal function as defined below:neutrophils = 1.5 × 109/L, platelets 80 × 109/L, hemoglobin =80 g/L, AST and ALT =2× the upper limit of the institutional normal range, total bilirubin =1.25× the upper limit of the institutional normal range, and creatinine concentration =120 µmol/L

• No history of thoracic surgery, radiation therapy, or chemotherapy

• Had measurable or assessable disease

Exclusion Criteria:

• Pregnancy or lactation at the time of enrollment

• Previous malignancy or other concomitant malignant disease

• Malignant pleural or pericardial effusions

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Drug:
• etoposide plus lobaplatin
Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin
• etoposide plus cisplatin
Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin

Locations

Country	Name	City	State
China	The affiliated hospital of Guizhou medical university	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Guizhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival(PFS)	PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.	up to 12 months
Secondary	Overall survival(OS)	Overall survival is defined as the time interval from date of diagnosis to date of death from any cause	up to 24 months
Secondary	Treatment toxicities	To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0	up to 12 months