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neoadjuvant_thymic Epithelial Tumor

NCT03858582 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-22

No results posted yet for this study

Summary

This is a Phase II single center, open-label, single arm study in patients with unresectable thymic epithelial tumors (Masaoka stage III, IVA). Patients will be treated with Pembrolizumab 200 mg, Docetaxel 75mg/m2, Cisplatin 75mg/m2 every 3 weeks for 3 cycles and will be evaluated for the operability. Patients with R0 resection will receive pembrolizumab 200mg for 32 cycles. Patient who had R1 resection will receive radiation 52.8Gy/24Fx with pembrolizumab 200mg for 32 cycles. Patients who had R2 resection will receive radiation 59.4Gy/27Fx with pembrolizumab 200mg for 32 cycles. Patients who showed non-progressive disease (PD) to initial neoadjuvant therapy but remained unresectable will receive radiation 59.4Gy/27Fx with 200mg for 32 cycles. Otherwise patients are off the study.

Conditions

  • Thymic Epithelial Tumor

Interventions

DRUG

pembrolizumab

pembrolizumab 200mg

RADIATION

Radiation

52.8Gy/24Fx or 59.4Gy/27Fx

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2022-04-01
Completion
2023-04-01

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858582 on ClinicalTrials.gov