NCT03613597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

July 22, 2018

Last Update Submit

February 3, 2020

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival(OS)

    up to 24 months

  • Treatment toxicities

    up to 12 months

Study Arms (2)

Etoposide plus Lobaplatin group

EXPERIMENTAL

Chemotherapy:etoposide plus lobaplatin (EL)

Drug: etoposide plus lobaplatin

Etoposide plus Cisplatin group

ACTIVE COMPARATOR

Chemotherapy:etoposide plus cisplatin (EP)

Drug: etoposide plus cisplatin

Interventions

etoposide plus lobaplatinDRUG

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

Also known as: EL
Etoposide plus Lobaplatin group
etoposide plus cisplatinDRUG

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

Also known as: EP
Etoposide plus Cisplatin group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or lactation at the time of enrollment
  • Previous malignancy or other concomitant malignant disease
  • Malignant pleural or pericardial effusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, 550004, China

RECRUITING

Related Publications (1)

  • Wang M, Ma Z, Li Q, Yang W, Chen X, Geng Y, Luo D, Hu Y, Wu B, Jiang W, Su S, Ouyang W, Lu B. Preliminary results of randomized phase II study of etoposide plus lobaplatin or etoposide plus cisplatin with concurrent thoracic radiotherapy in the treatment of limited-stage small cell lung cancer. Anticancer Drugs. 2023 Nov 1;34(10):1183-1189. doi: 10.1097/CAD.0000000000001501. Epub 2023 Jan 24.

    PMID: 36727741DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

EtoposidelobaplatinCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • ShengFa Su, PhD,MD

    sushengfa2005@163.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ShengFa Su, PhD,MD

CONTACT

0086-851-86513076sushengfa2005@163.com

Bing Lu, MD

CONTACT

474111382@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 3, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(1)