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

Sponsor
Guizhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03613597
Collaborator
(none)
118
Enrollment
1
Location
2
Arms
43
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: etoposide plus lobaplatin
  • Drug: etoposide plus cisplatin
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Treatment toxicities [up to 12 months]

      To assess and record nausea, vomiting, hematologic toxicity,radiation oesophagitis and other treantment complications by CTCAE v4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The affiliated hospital of Guizhou medical university Guiyang Guizhou China 550004

    Sponsors and Collaborators

    • Guizhou Medical University

    Investigators

    • Principal Investigator: ShengFa Su, PhD,MD, sushengfa2005@163.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ShengFa Su, Professor, Guizhou Medical University
    ClinicalTrials.gov Identifier:
    NCT03613597
    Other Study ID Numbers:
    • L-SCLC-001
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Etoposide
    Etoposide phosphate

    Study Results

    No Results Posted as of Feb 5, 2020