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Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02633514
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kailiang Wu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Thymoma and Thymic Carcinoma Drug: Cisplatin Drug: Etoposide Radiation: radiotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arm Intervention/treatment
Experimental: Radiochemotherapy
adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
Drug: Cisplatin
25mg/m2,iv gtt,d1-3
Other Name: DDP

Drug: Etoposide
75mg/m2,iv gtt,d1-3
Other Name: VP-16

Radiation: radiotherapy
60Gy/30Fx

Sham Comparator: radiotherapy
adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
Radiation: radiotherapy
60Gy/30Fx




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
    from registration to disease progression or death.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    from registration to death as a result of any cause

  2. Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    Assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633514


Contacts
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Contact: Kailiang Wu, MD.PhD. +86 64175590 ext 86722 wukailiang@aliyun.com
Contact: Xingwen Fan, MD +8613651669687 wenxingfan@126.com

Locations
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China, Shanghai
Kailiang Wu Recruiting
Shanghai, Shanghai, China, 20032
Contact: Kailiang Wu, M.D. Ph. D.    +86 64175590 ext 86722    wukailiang@aliyun.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Kailiang Wu, MD. PhD Fudan University

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Responsible Party: Kailiang Wu, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02633514     History of Changes
Other Study ID Numbers: 1508151-6
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kailiang Wu, Fudan University:
thymoma
thymic carcinoma
adjuvant radiotherapy
adjuvant radiochemotherapy
incomplete resection

Additional relevant MeSH terms:
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Carcinoma
Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action