Small-cell Lung Cancer
Conditions
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.
Interventions
DRUGetoposide plus lobaplatin
Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin
Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin
Sponsors
Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Treatment toxicities | up to 12 months | To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactShengFa Su, PhD,MD
Backup ContactBing Lu, MD
Outcome results
None listed