MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

Mediastinal Tumor Clinical Trial

Official title:

A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163509
• Other study ID #: GASTO-1078
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: Daquan Wang, M.D
• Phone: +86-020-87343031
• Email: wangdq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mediastinal Neoplasms
• Mediastinal Tumor

Intervention

Combination Product:
• Unity-based MR-Linac guided Radiotherapy
The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.

Locations

Country	Name	City	State
China	Hui Liu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Raaymakers BW, Jürgenliemk-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local-recurrence free survival		2 years
Secondary	Objective response rate		2 months
Secondary	Progression-free survival		2 years
Secondary	Overall survival		2 years
Secondary	Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0		2 months
Secondary	Dose coverage to targets and normal organs		2 months