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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
Sun Yat-sen 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 Unresectable or Recurrent Thymoma and Thymic Carcinoma, Hypofractionated Chemoradiotherapy, Thymosin a1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 4, 2018
Last Updated
November 27, 2021
Sponsor
Sun Yat-sen University
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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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21847050
Citation
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Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

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