AzTrials
AzTrials

Mediastinal TumorPhase 2NCT05163509

MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

A Phase 2 study testing Unity-based MR-Linac guided Radiotherapy in people with Mediastinal Tumor, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mediastinal Tumor
What is being tested?
Unity-based MR-Linac guided Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
1 Oct 2021to 1 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Daquan Wang, M.D contact

+86-020-87343031

wangdq@sysucc.org.cn

Bo Qiu, M.D contact

+86-020-87343031

qiubo@sysucc.org.cn

China1 site, 1 recruiting

  • Hui Liu

    Guangzhou, Guangdong, 510060

    Hui Liu, Prof., +86-020-87343031, liuhui@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Unity-based MR-Linac guided Radiotherapy
Keywords
Mediastinal Tumor, MR-Linac, Radiotherapy
Medical subject headings
Mediastinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unity-based MR-Linac guided RadiotherapyCombination product

    The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.

Study groups in NCT05163509
Study groupRoleWhat they receive
MR-Linac Guided Adaptive RadiotherapyExperimentalPatients will receive Adaptive Radiotherapy on the MR-Linac treatment machine.
Receives: Combination Product: Unity-based MR-Linac guided Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local-recurrence free survival

    Measured: 2 years

Secondary outcomes (5)

  1. Objective response rate

    Measured: 2 months

  2. Progression-free survival

    Measured: 2 years

  3. Overall survival

    Measured: 2 years

  4. Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0

    Measured: 2 months

  5. Dose coverage to targets and normal organs

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163509
Sponsor's protocol ID
GASTO-1078
Status last verified
Dec 2021
First submitted
15 Dec 2021
Last updated
20 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20551960

  • 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.

    PubMed 12128137

  • 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.

    PubMed 25322150

  • 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.

    PubMed 16980682

  • 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.

    PubMed 19451689

  • Stemkens B, Tijssen RHN, de Senneville BD, Lagendijk JJW, van den Berg CAT. 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.

    PubMed 27362636

  • 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.

    PubMed 28543069

  • 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.

    PubMed 26531846

  • 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.

    PubMed 28749375

  • 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.

    PubMed 29135471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Unity-based MR-Linac guided Radiotherapy in people with Mediastinal Tumor, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daquan Wang, M.D (+86-020-87343031, wangdq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local-recurrence free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163509, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in