Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung Cancer
- Conditions
- Small-cell Lung Cancer
- Interventions
- Registration Number
- NCT03613597
- Lead Sponsor
- Guizhou Medical University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 118
- 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
- Pregnancy or lactation at the time of enrollment
- Previous malignancy or other concomitant malignant disease
- Malignant pleural or pericardial effusions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etoposide plus Lobaplatin group etoposide plus lobaplatin Chemotherapy:etoposide plus lobaplatin (EL) Etoposide plus Cisplatin group etoposide plus cisplatin Chemotherapy:etoposide plus cisplatin (EP)
- Primary Outcome Measures
Name Time Method Progression-free survival(PFS) up to 12 months PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Treatment toxicities up to 12 months To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0
Overall survival(OS) up to 24 months Overall survival is defined as the time interval from date of diagnosis to date of death from any cause
Trial Locations
- Locations (1)
The affiliated hospital of Guizhou medical university
🇨🇳Guiyang, Guizhou, China