ClinicalTrials.gg
Sign In
Not yet recruitingNCT07879417Updated Oct 16, 2026

Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis

A Phase 2 interventional study of hypofractionated radiotherapy guided by optical surface imaging and FBCT and hypofractionated radiotherapy guided by CBCT in Thymoma and Thymic Carcinoma and Pleural Metastasis, sponsored by Sun Yat-sen University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This trial plans to conduct a prospective, randomized controlled phase II clinical study to explore the efficacy and safety of hypofractionated radiotherapy guided by optical surface imaging combined with FBCT in patients with thymoma and pleural metastasis.

02

Conditions studied

  • Thymoma and Thymic Carcinoma
  • Pleural Metastasis

Browse trials for

Keywords

  • radiotherapy
  • FBCT
03

In context

Thymoma

127 studies on the registry are indexed under Thymoma; 37 are open to participants now.

This study's planned enrollment of 234 is above the median of 40 across 102 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically confirmed thymoma (type AB, B1-B3, type C).
  • Presence of measurable pleural metastatic lesions per RECIST criteria.
  • Aged ≥18 and \<75 years, no restriction on gender.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • No prior thoracic radiotherapy, immunotherapy or biologic therapy.
  • Serum hemoglobin ≥10 g/dL, platelets ≥100,000/μL, absolute neutrophil count (ANC) ≥1,500/μL.
  • Serum creatinine ≤1.25 × upper normal limit (UNL), or creatinine clearance ≥60 mL/min.
  • Serum total bilirubin ≤1.5 × UNL; AST (SGOT) and ALT (SGPT) ≤2.5 × UNL; alkaline phosphatase ≤5 × UNL.
  • FEV1 >0.8 L.
  • CB6 within normal limits.
  • The patient and their family agree and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Prior or concurrent other malignancy at the time of treatment, except for non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Presence of uncontrolled comorbidities (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, ongoing immunosuppressive therapy).
  • Pregnant or lactating women; females without pregnancy test within 14 days prior to the first administration, and pregnant females.
  • Pregnant, lactating individuals, or fertile individuals without effective contraception.
  • Subjects with bleeding diathesis.
  • Participation in another clinical trial within 30 days prior to enrollment in this study.
  • Individuals with drug addiction such as illicit drug use, chronic alcoholism, or patients with AIDS.
  • Uncontrolled seizure disorders or psychiatric illness resulting in impaired capacity for self-care.
  • History of severe allergy or idiosyncratic hypersensitivity.
  • Subjects whom the investigator considers inappropriate for participation in this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
234 participants (estimated)

Study arms

  • Experimental
    The experimental group

    All patients will receive hypofractionated radiotherapy guided by optical surface imaging and FBCT.

    Device: hypofractionated radiotherapy guided by optical surface imaging and FBCT

  • Active comparator
    The control group

    All patients will receive hypofractionated radiotherapy guided by conventional CBCT.

    Device: hypofractionated radiotherapy guided by CBCT

Interventions

  • Devicehypofractionated radiotherapy guided by optical surface imaging and FBCT

    FBCT combined with optical surface imaging is applied to guide and deliver hypofractionated radiotherapy.

  • Devicehypofractionated radiotherapy guided by CBCT

    Conventional CBCT is used to guide and deliver hypofractionated radiotherapy.

06

What researchers measure

Primary outcomes

  1. Incidence of radiation pneumonitis

    Radiation pneumonitis are assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Time frame: 12 months

Secondary outcomes

  1. Progression free survival

    Progression-free survival (PFS) is defined as the time from randomization to the first documentation of disease progression or death from any cause, whichever occurs first.

    Time frame: 2 years

  2. Overall survival

    Overall survival (OS) is defined as the time from randomization to death from any cause.

    Time frame: 2 years

  3. Treatment-related toxicity

    Treatment-related adverse events (toxicities) are assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Wang CL, Gao LT, Lyu CX, Wang JM, Liu J, Gu HL, Liu Y, Fu XL. Intensity Modulated Radiation Therapy for Pleural Recurrence of Thymoma: A Prospective Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):775-782. doi: 10.1016/j.ijrobp.2020.09.058. Epub 2020 Oct 9. PubMed 33039590 ↗
  • Yokoi K, Matsuguma H, Nakahara R, Kondo T, Kamiyama Y, Mori K, Miyazawa N. Multidisciplinary treatment for advanced invasive thymoma with cisplatin, doxorubicin, and methylprednisolone. J Thorac Oncol. 2007 Jan;2(1):73-8. doi: 10.1097/JTO.0b013e31802bafc8. PubMed 17410014 ↗
  • Lucchi M, Mussi A, Basolo F, Ambrogi MC, Fontanini G, Angeletti CA. The multimodality treatment of thymic carcinoma. Eur J Cardiothorac Surg. 2001 May;19(5):566-9. doi: 10.1016/s1010-7940(01)00666-2. PubMed 11343932 ↗
  • Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051. PubMed 18222230 ↗
  • Gao L, Wang C, Fang W, Zhang J, Lv C, Fu S. Outcome of multimodality treatment for 188 cases of type B3 thymoma. J Thorac Oncol. 2013 Oct;8(10):1329-34. doi: 10.1097/JTO.0b013e31829ceb50. PubMed 24457243 ↗
  • Detterbeck F, Youssef S, Ruffini E, Okumura M. [A review of prognostic factors in thymic malignancies]. Zhongguo Fei Ai Za Zhi. 2014 Feb;17(2):130-6. doi: 10.3779/j.issn.1009-3419.2014.02.11. No abstract available. Chinese. PubMed 24581164 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07879417
Lead sponsor
Sun Yat-sen University
Responsible party
Hui Liu (Prof., Sun Yat-sen University) — Principal investigator
First posted
Oct 16, 2026
Start date
Oct 12, 2026 (estimated)
Primary completion
Oct 12, 2028 (estimated)
Completion
Oct 12, 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

DaQuan Wang
Contact
wangdq@sysucc.org.cn
+862087343031
Hui Liu
Contact
liuhui@sysucc.org.cn
+862087343031

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thymoma →

Other studies from this sponsor

Sun Yat-sen University →

Start the discussion