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

Primary Purpose

Small-cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

etoposide plus lobaplatin

etoposide plus cisplatin

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The affiliated hospital of Guizhou medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etoposide plus Lobaplatin group

Etoposide plus Cisplatin group

Arm Description

Chemotherapy:etoposide plus lobaplatin (EL)

Chemotherapy:etoposide plus cisplatin (EP)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival(OS)

Overall survival is defined as the time interval from date of diagnosis to date of death from any cause

Treatment toxicities

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

Full Information

NCT ID

NCT03613597

First Posted

July 22, 2018

Last Updated

February 3, 2020

Sponsor

Guizhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03613597

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guizhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small-cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Etoposide plus Lobaplatin group

Arm Type

Experimental

Arm Description

Chemotherapy:etoposide plus lobaplatin (EL)

Arm Title

Etoposide plus Cisplatin group

Arm Type

Active Comparator

Arm Description

Chemotherapy:etoposide plus cisplatin (EP)

Intervention Type

Drug

Intervention Name(s)

etoposide plus lobaplatin

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

etoposide plus cisplatin

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival(PFS)

Description

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Overall survival(OS)

Description

Overall survival is defined as the time interval from date of diagnosis to date of death from any cause

Time Frame

up to 24 months

Title

Treatment toxicities

Description

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

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ShengFa Su, PhD,MD

Phone

0086-851-86513076

sushengfa2005@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Lu, MD

474111382@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ShengFa Su, PhD,MD

Organizational Affiliation

sushengfa2005@163.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

The affiliated hospital of Guizhou medical university

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shengfa Su, PhD,MD

Phone

86-13608550432

sushengfa2005@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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