Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
Primary Purpose
Thymoma and Thymic Carcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Thymosin a1
hypofractionated radiotherapy
concurrent chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma and Thymic Carcinoma focused on measuring Unresectable or Recurrent Thymoma and Thymic Carcinoma, Hypofractionated Chemoradiotherapy, Thymosin a1
Eligibility Criteria
Inclusion Criteria:
- Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors.
- 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 disease or recurrent intrathoracic disease which could be encompassed within radiation fields.
- 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.
- 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.
Sites / Locations
- Sun yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Expeiment
Arm Description
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used. All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
Outcomes
Primary Outcome Measures
Progression-Free Survival
Secondary Outcome Measures
Quality of Life score
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire
Overall Survival
Full Information
NCT ID
NCT03663764
First Posted
September 4, 2018
Last Updated
November 27, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03663764
Brief Title
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
Official Title
Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).
Detailed Description
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma and Thymic Carcinoma
Keywords
Unresectable or Recurrent Thymoma and Thymic Carcinoma, Hypofractionated Chemoradiotherapy, Thymosin a1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Expeiment
Arm Type
Experimental
Arm Description
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
Intervention Type
Drug
Intervention Name(s)
Thymosin a1
Intervention Description
All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiotherapy
Intervention Description
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
Intervention Type
Drug
Intervention Name(s)
concurrent chemoradiotherapy
Intervention Description
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Primary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of Life score
Description
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire
Time Frame
1 year
Title
Overall Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors.
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 disease or recurrent intrathoracic disease which could be encompassed within radiation fields.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
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