Back to resultsMR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Primary Purpose
Mediastinal Tumor
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Unity-based MR-Linac guided Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Mediastinal Tumor focused on measuring Mediastinal Tumor, MR-Linac, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years
- Histologically or cytologically confirmed mediastinal cancer
- Patients with inoperable mediastinal lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
- Informed-consent
Exclusion Criteria:
- Patients with contraindications for MRI
- Previous radiotherapy or excision for mediastinal tumor
- The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
- A cavity over 2cm in diameter of primary tumor or metastasis Bleeding tendency or coagulation disorder
- Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
- The use of full-dose anticoagulation within the past 1 month
- Severe vascular disease occurred within 6 months
- Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
- Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
- Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
- Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
- Urine protein 3-4+, or 24h urine protein quantitative >1g
- Severe uncontrolled disease
- Uncontrollable seizure or psychotic patients without self-control ability
- Women in pregnancy, lactation period
- Other not suitable conditions determined by the investigators
Sites / Locations
- Hui LiuRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-Linac Guided Adaptive Radiotherapy
Arm Description
Patients will receive Adaptive Radiotherapy on the MR-Linac treatment machine.
Outcomes
Primary Outcome Measures
Local-recurrence free survival
Secondary Outcome Measures
Objective response rate
Progression-free survival
Overall survival
Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0
Dose coverage to targets and normal organs
Full Information
NCT ID
NCT05163509
First Posted
December 15, 2021
Last Updated
December 15, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05163509
Brief Title
MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Official Title
A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 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 is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.
Detailed Description
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.
Patients will receive radiotherapy on the MR-Linac treatment machine. The primary end point is 2-year local-recurrence free survival. The secondary end points are objective response rate, 2-y PFS, 2-y OS, safety of treatment, dose coverage of targets and dose to normal organs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Tumor
Keywords
Mediastinal Tumor, MR-Linac, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-Linac Guided Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
Patients will receive Adaptive Radiotherapy on the MR-Linac treatment machine.
Intervention Type
Combination Product
Intervention Name(s)
Unity-based MR-Linac guided Radiotherapy
Intervention Description
The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.
Primary Outcome Measure Information:
Title
Local-recurrence free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
2 months
Title
Progression-free survival
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
Title
Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0
Time Frame
2 months
Title
Dose coverage to targets and normal organs
Time Frame
2 months
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:
Aged 18-75 years
Histologically or cytologically confirmed mediastinal cancer
Patients with inoperable mediastinal lesions
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN
Informed-consent
Exclusion Criteria:
Patients with contraindications for MRI
Previous radiotherapy or excision for mediastinal tumor
The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)
A cavity over 2cm in diameter of primary tumor or metastasis Bleeding tendency or coagulation disorder
Hemoptysis (1/2 teaspoon blood/day) happened within 1 month
The use of full-dose anticoagulation within the past 1 month
Severe vascular disease occurred within 6 months
Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months
Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg)
Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
Urine protein 3-4+, or 24h urine protein quantitative >1g
Severe uncontrolled disease
Uncontrollable seizure or psychotic patients without self-control ability
Women in pregnancy, lactation period
Other not suitable conditions determined by the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daquan Wang, M.D
Phone
+86-020-87343031
Email
wangdq@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Qiu, M.D
Phone
+86-020-87343031
Email
qiubo@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Prof.
Phone
+86-020-87343031
Email
liuhui@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20551960
Citation
Kunitoh H, Tamura T, Shibata T, Takeda K, Katakami N, Nakagawa K, Yokoyama A, Nishiwaki Y, Noda K, Watanabe K, Saijo N; JCOG Lung Cancer Study Group. A phase II trial of dose-dense chemotherapy, followed by surgical resection and/or thoracic radiotherapy, in locally advanced thymoma: report of a Japan Clinical Oncology Group trial (JCOG 9606). Br J Cancer. 2010 Jun 29;103(1):6-11. doi: 10.1038/sj.bjc.6605731. Epub 2010 Jun 15.
Results Reference
background
PubMed Identifier
12128137
Citation
Jaffray DA, Siewerdsen JH, Wong JW, Martinez AA. Flat-panel cone-beam computed tomography for image-guided radiation therapy. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1337-49. doi: 10.1016/s0360-3016(02)02884-5.
Results Reference
background
PubMed Identifier
25322150
Citation
Lagendijk JJ, Raaymakers BW, Van den Berg CA, Moerland MA, Philippens ME, van Vulpen M. MR guidance in radiotherapy. Phys Med Biol. 2014 Nov 7;59(21):R349-69. doi: 10.1088/0031-9155/59/21/R349. Epub 2014 Oct 16. No abstract available.
Results Reference
background
PubMed Identifier
16980682
Citation
Khoo VS, Joon DL. New developments in MRI for target volume delineation in radiotherapy. Br J Radiol. 2006 Sep;79 Spec No 1:S2-15. doi: 10.1259/bjr/41321492.
Results Reference
background
PubMed Identifier
19451689
Citation
Raaymakers BW, Lagendijk JJ, Overweg J, Kok JG, Raaijmakers AJ, Kerkhof EM, van der Put RW, Meijsing I, Crijns SP, Benedosso F, van Vulpen M, de Graaff CH, Allen J, Brown KJ. Integrating a 1.5 T MRI scanner with a 6 MV accelerator: proof of concept. Phys Med Biol. 2009 Jun 21;54(12):N229-37. doi: 10.1088/0031-9155/54/12/N01. Epub 2009 May 19.
Results Reference
background
PubMed Identifier
27362636
Citation
Stemkens B, Tijssen RH, de Senneville BD, Lagendijk JJ, van den Berg CA. Image-driven, model-based 3D abdominal motion estimation for MR-guided radiotherapy. Phys Med Biol. 2016 Jul 21;61(14):5335-55. doi: 10.1088/0031-9155/61/14/5335. Epub 2016 Jun 30.
Results Reference
background
PubMed Identifier
28543069
Citation
Dietz B, Yip E, Yun J, Fallone BG, Wachowicz K. Real-time dynamic MR image reconstruction using compressed sensing and principal component analysis (CS-PCA): Demonstration in lung tumor tracking. Med Phys. 2017 Aug;44(8):3978-3989. doi: 10.1002/mp.12354. Epub 2017 Jun 28.
Results Reference
background
PubMed Identifier
26531846
Citation
Glitzner M, Crijns SP, de Senneville BD, Kontaxis C, Prins FM, Lagendijk JJ, Raaymakers BW. On-line MR imaging for dose validation of abdominal radiotherapy. Phys Med Biol. 2015 Nov 21;60(22):8869-83. doi: 10.1088/0031-9155/60/22/8869. Epub 2015 Nov 4.
Results Reference
background
PubMed Identifier
28749375
Citation
Kontaxis C, Bol GH, Stemkens B, Glitzner M, Prins FM, Kerkmeijer LGW, Lagendijk JJW, Raaymakers BW. Towards fast online intrafraction replanning for free-breathing stereotactic body radiation therapy with the MR-linac. Phys Med Biol. 2017 Aug 21;62(18):7233-7248. doi: 10.1088/1361-6560/aa82ae.
Results Reference
background
PubMed Identifier
29135471
Citation
Raaymakers BW, Jurgenliemk-Schulz IM, Bol GH, Glitzner M, Kotte ANTJ, van Asselen B, de Boer JCJ, Bluemink JJ, Hackett SL, Moerland MA, Woodings SJ, Wolthaus JWH, van Zijp HM, Philippens MEP, Tijssen R, Kok JGM, de Groot-van Breugel EN, Kiekebosch I, Meijers LTC, Nomden CN, Sikkes GG, Doornaert PAH, Eppinga WSC, Kasperts N, Kerkmeijer LGW, Tersteeg JHA, Brown KJ, Pais B, Woodhead P, Lagendijk JJW. First patients treated with a 1.5 T MRI-Linac: clinical proof of concept of a high-precision, high-field MRI guided radiotherapy treatment. Phys Med Biol. 2017 Nov 14;62(23):L41-L50. doi: 10.1088/1361-6560/aa9517.
Results Reference
background
Learn more about this trial
MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor
We'll reach out to this number within 24 hrs