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

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

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.

Study Overview

• Status: Unknown
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: etoposide plus lobaplatin; Drug: etoposide plus cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
      • Contact: Shengfa Su, PhD,MD; Phone Number: 86-13608550432; Email: sushengfa2005@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Etoposide plus Lobaplatin group; Chemotherapy:etoposide plus lobaplatin (EL)	Drug: etoposide plus lobaplatin; Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin; Other Names: EL
ACTIVE_COMPARATOR: Etoposide plus Cisplatin group; Chemotherapy:etoposide plus cisplatin (EP)	Drug: etoposide plus cisplatin; Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin; Other Names: EP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Treatment toxicities	To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0	up to 12 months

Collaborators and Investigators

• Sponsor: Guizhou Medical University
• Investigators: Principal Investigator: ShengFa Su, PhD,MD, sushengfa2005@163.com

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Etoposide phosphate; Cisplatin
• Other Study ID Numbers: L-SCLC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No