Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

December 3, 2023 updated by: Kailiang Wu, Fudan University

A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma

This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20032
        • Recruiting
        • Kailiang Wu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
Drug: Cisplatin
25mg/m2,iv gtt,d1-3
Other Names:
  • DDP
Drug: Etoposide
75mg/m2,iv gtt,d1-3
Other Names:
  • VP-16
Radiation: radiotherapy
60Gy/30Fx
Sham Comparator: radiotherapy
adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
Radiation: radiotherapy
60Gy/30Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 2 years
from registration to disease progression or death.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
from registration to death as a result of any cause
2 years
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 2 years
Assessed by CTCAE v4.0
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Kailiang Wu, MD. PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimated)

December 17, 2015

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508151-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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