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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etoposide plus Lobaplatin group

Chemotherapy:etoposide plus lobaplatin (EL)

Group Type EXPERIMENTAL

etoposide plus lobaplatin

Intervention Type DRUG

Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin

Etoposide plus Cisplatin group

Chemotherapy:etoposide plus cisplatin (EP)

Group Type ACTIVE_COMPARATOR

etoposide plus cisplatin

Intervention Type DRUG

Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin

Interventions

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etoposide plus lobaplatin

Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin

Intervention Type DRUG

etoposide plus cisplatin

Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin

Intervention Type DRUG

Other Intervention Names

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EL EP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No