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RecruitingNCT06692062Updated Nov 18, 2024

Hypofractionated Radiotherapy for Thymic Epithelial Tumors

An interventional study of Hypofractionated Radiation Therapy in Thymoma and Thymic Carcinoma, Thymoma and Thymic Cancer, sponsored by Rongrong Zhou. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by Rongrong Zhou · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if hypofractionated radiotherapy works to shorten the treatment time without increasing the side effects in patients of thymic epithelial tumors. The main questions it aims to answer are:

  • Does Hypofractionated radiotherapy provide better results?
  • Can hypofractionated radiotherapy reduce toxic and side effects compared with conventional radiotherapy? Researchers will compare the efficacy and safety of hypofractionated radiotherapy after thymic tumor surgery.

Participants will:

  • Receive hypofractionated radiotherapy or conventional radiotherapy
  • Visit the hospital regularly once every 12 weeks for checkups and tests
Read the detailed description

According to the World Health Organization histological classification system, thymic epithelial tumors (TET) are divided into thymoma and thymic carcinoma. Surgery is the main treatment for thymic tumors, and radiotherapy (RT), as an important auxiliary method of surgery, also plays an irreplaceable role in all stages of thymoma.

Hypofractionated radiotherapy is a common mode of radiotherapy for thoracic tumors. Unlike conventional radiotherapy, hypofractionated radiotherapy has a higher single dose and a shorter course of treatment. Because it improves the treatment efficiency, it can reduce the treatment time of patients and medical institutions and the cost of patients.

In the postoperative radiotherapy stage, conventional radiotherapy and hypofractionated radiotherapy were used. The course of hypofractionated radiotherapy was shorter than that of conventional radiotherapy. Patients chose to accept hypofractionated radiotherapy as the hypofractionated group, but not the conventional group.

02

Conditions studied

  • Thymoma and Thymic Carcinoma
  • Thymoma
  • Thymic Cancer
  • Thymic Epithelial Tumor

Keywords

  • thymoma
  • hypofractionated radiotherapy
  • thymic carcinoma
03

In context

Thymoma

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

This study's planned enrollment of 100 is above the median of 44 across 108 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Rongrong Zhou is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

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

  1. Patients must provide written .
  2. 18 years old ≤ age \<75 years old.
  3. Thymoma confirmed by pathology: type A, type AB, type B1, type B2, type B3. Thymic carcinoma. Patients with previous thymectomy were required to have complete surgical related data.
  4. Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
  5. performance status 0-2.
  6. Expected survival time > 1 year.
  7. Participants of childbearing age must agree to use effective during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
  8. Patients who are not lactating.
  9. Sufficient bone marrow reserve and good function of important organs.

Exclusion criteria

Exclusion Criteria:

  1. patients with prior thoracic radiotherapy;
  2. diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
  3. Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
  4. Patients with other malignant tumors that are not under stable control;
  5. Known history of mental illness, substance abuse, alcohol or drug abuse.
  6. Other conditions deemed unsuitable for enrollment by the attending physician.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Hypofractionated Radiotherapy

    R0 resection: 42-48 Gy/14-16f or 40-44 Gy or 10-11f,40 Gy/8f R1 resection: 48-51 Gy/16-17f or 44-48 Gy/11-12f or 40-45 Gy/8-9f R2 resection: 51-60 Gy/17-20f or 48-56 Gy/12-14f or 45 -60Gy/9-12f

    Radiation: Hypofractionated Radiation Therapy

  • No intervention
    Conventional Radiotherapy

    R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

Interventions

  • RadiationHypofractionated Radiation Therapy

    R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f

06

What researchers measure

Primary outcomes

  1. 3-year PFS

    Time from enrollment to disease progression or death.

    Time frame: The patients were followed up for 3 years from enrollment to disease progression or death.

Secondary outcomes

  1. toxicity

    Any adverse medical event that occurred between the time the patient provided informed consent and was enrolled in the trial and the date of the last follow-up visit.

    Time frame: Patients were followed from enrollment until 3 years.

  2. 3-year OS

    Time from patient enrollment to patient death.

    Time frame: The patients were followed up for 3 years from enrollment to death.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06692062
Lead sponsor
Rongrong Zhou
Responsible party
Rongrong Zhou (Deputy Director of Department of Oncology, Xiangya Hospital of Central South University) — Sponsor-investigator
First posted
Nov 18, 2024
Start date
Oct 1, 2024
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Nov 18, 2024

Study contacts

Rongrong Zhou, MD, PHD
Contact
zhourr@csu.edu.cn
+8613875898127

Oversight

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

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