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Study of Thymosin a1 During Chemoradiotherapy For Unresectable Thymoma and 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: NCT03663764
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Study Description
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Brief Summary:
This Phase II study is to determine the efficacy of thymosin a1 during chemoradiotherapy for unresectable thymoma and thymic carcinoma

Condition or disease Intervention/treatment Phase
Thymoma and Thymic Carcinoma Drug: Thymosin a1 Phase 2

Detailed Description:

This Phase II study is to determine the efficacy of thymosin a1 during chemoradiotherapy for unresectable thymoma and thymic carcinoma.

All patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with thoracic radiotherapy of 66 Gy/22 fractions. Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Phase Ⅱ Study of Thymosin a1 During Chemoradiotherapy For Unresectable Thymoma and Thymic Carcinoma
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Expeiment
Patients in experimental group received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with thoracic radiotherapy of 66 Gy/22 fractions. Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
 Drug: Thymosin a1
All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Time to a 10 point (10%) deterioration in Quality of Life score [ Time Frame: 3 years ]
    EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire

  2. Overall Survival [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic confirmation of thymoma or thymic carcinoma.
  • Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Unresectable, refusing surgery or after R2 surgery.
  • Previously treated with chemotherapy or treatment-naive.
  • No previous chest radiotherapy, immunotherapy or biotherapy.
  • White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
  • FEV1 >0.8 L
  • CB6 within normal limits
  • Patients and their family signed the informed consents

Exclusion Criteria:

  • Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
  • Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.
  • Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia).
  • Malignant pleural effusion or pericardial effusion.
  • Weight loss >10% within the past 3 months.
  • Recruited in other clinical trials within 30 days
  • Drug addiction, long-term alcohol abuse and AIDS patients.
  • Uncontrollable epileptic attack or psychotic patients without self-control ability.
  • Severe allergy or idiosyncrasy.
  • Not suitable for this study judged by researchers.
Contacts and Locations
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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): NCT03663764


Contacts
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Contact: Bo Qiu, Attending +86-020-87343031 qiubo@sysucc.org.cn
Contact: Hui Liu, Professor +86-020-87343031 liuhui@sysucc.org.cn

Locations
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China, Guangdong
Sun yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Bo Qiu, Attending    +86-020-87343031    qiubo@sysucc.org.cn   
Contact: Hui Liu, Professor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Professor Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03663764    
Other Study ID Numbers: GASTO-1042
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Hui Liu, Sun Yat-sen University:
Unresectable Thymoma and Thymic Carcinoma
Chemoradiotherapy
Thymosin a1
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