Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer
A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
1 other identifier
interventional
72
1 country
1
Brief Summary
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 5, 2020
February 1, 2020
2 years
July 21, 2018
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Tumor Response will be evaluated using the RECIST 1.1 criteria.ORR is Partial response (PR) and complete response (CR).
>4 weeks post treatment
Secondary Outcomes (3)
Treatment toxicities
up to 12 months
Progression-free survival(PFS)
up to 12 months
Overall survival(OS)
up to 12 months
Study Arms (2)
Arm A
EXPERIMENTALChemotherapy:irinotecan plus lobaplatin
Arm B
ACTIVE COMPARATORChemotherapy:irinotecan
Interventions
Eligibility Criteria
You may qualify if:
- Relapsed SCLC
- Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC
- At least 30 days after the completion of first-line chemotherapy
- Either sex, age between 18 to 70 years
- Expected life time ≥ 3 months
- 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 and organ 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; Creatinineconcentration ≤120 μmol/L
- Had measurable or assessable disease
You may not qualify if:
- Concomitant with other malignant disease
- Pregnancy or lactation at the time of enrollment
- Any contraindications for chemotherapy
- Received target therapy or immunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ShengFa Sulead
Study Sites (1)
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, 550004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ShengFa Su, PhD,MD
The Affiliated Hospital Of Guizhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2018
First Posted
August 3, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2021
Last Updated
February 5, 2020
Record last verified: 2020-02