Clinical trial NCT03613597: Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small-cell Lung Cancer
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: up to 24 months
measure: Treatment toxicities
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The affiliated hospital of Guizhou medical university
state: Guizhou
Study officials:
affiliation: sushengfa2005@163.com
name: ShengFa Su, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: