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Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

Primary Purpose

Thymoma and Thymic Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cisplatin
Etoposide
radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma and Thymic Carcinoma focused on measuring thymoma, thymic carcinoma, adjuvant radiotherapy, adjuvant radiochemotherapy, incomplete resection

Eligibility Criteria

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

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.

Sites / Locations

  • Kailiang WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Radiochemotherapy

radiotherapy

Arm Description

adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)

adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)

Outcomes

Primary Outcome Measures

Progression free survival
from registration to disease progression or death.

Secondary Outcome Measures

Overall survival
from registration to death as a result of any cause
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Assessed by CTCAE v4.0

Full Information

First Posted
December 15, 2015
Last Updated
February 5, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02633514
Brief Title
Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma
Official Title
A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma and Thymic Carcinoma
Keywords
thymoma, thymic carcinoma, adjuvant radiotherapy, adjuvant radiochemotherapy, incomplete resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiochemotherapy
Arm Type
Experimental
Arm Description
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
Arm Title
radiotherapy
Arm Type
Sham Comparator
Arm Description
adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
25mg/m2,iv gtt,d1-3
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
75mg/m2,iv gtt,d1-3
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
60Gy/30Fx
Primary Outcome Measure Information:
Title
Progression free survival
Description
from registration to disease progression or death.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
from registration to death as a result of any cause
Time Frame
2 years
Title
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Description
Assessed by CTCAE v4.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kailiang Wu, MD.PhD.
Phone
+86 64175590
Ext
86722
Email
wukailiang@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xingwen Fan, MD
Phone
+8613651669687
Email
wenxingfan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kailiang Wu, MD. PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kailiang Wu
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kailiang Wu, M.D. Ph. D.
Phone
+86 64175590
Ext
86722
Email
wukailiang@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

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