Thymoma and Thymic CarcinomaNCT06692062
Hypofractionated Radiotherapy for Thymic Epithelial Tumors
A study testing Hypofractionated Radiation Therapy in people with Thymoma and Thymic Carcinoma and Thymoma, run by Rongrong Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma and Thymic Carcinoma, Thymoma, Thymic Cancer
- What is being tested?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients must provide written informed consent.
- 18 years old ≤ age <75 years old.
- 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.
- Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
- ECOG performance status 0-2.
- Expected survival time > 1 year.
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- Participants of childbearing age must agree to use effective contraception during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
- Patients who are not lactating.
- Sufficient bone marrow reserve and good function of important organs.
Who cannot join
- patients with prior thoracic radiotherapy;
- diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
- Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
- Patients with other malignant tumors that are not under stable control;
- Known history of mental illness, substance abuse, alcohol or drug abuse.
- Other conditions deemed unsuitable for enrollment by the attending physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Rongrong Zhou, MD, PHD, +8613875898127, zhourr@csu.edu.cn
About this study
Official title: A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors
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.
- Being tested
- Hypofractionated Radiation Therapy
- Keywords
- thymoma, hypofractionated radiotherapy, thymic carcinoma
- Medical subject headings
- Thymoma, Thymus Neoplasms, Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | 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 Receives: Radiation: Hypofractionated Radiation Therapy |
| Conventional Radiotherapy | No intervention | R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year PFS
Time from enrollment to disease progression or death.
Measured: The patients were followed up for 3 years from enrollment to disease progression or death.
Secondary outcomes (2)
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.
Measured: Patients were followed from enrollment until 3 years.
3-year OS
Time from patient enrollment to patient death.
Measured: The patients were followed up for 3 years from enrollment to death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymoma and Thymic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rongrong Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rongrong Zhou, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692062
- Sponsor's protocol ID
- 202401009
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Hypofractionated Radiotherapy for Thymic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT06692062
- Acronym / sponsor ID
- 202401009
- Keywords
- thymoma, hypofractionated radiotherapy, thymic carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rongrong ZhouUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | Radiation: Hypofractionated Radiation TherapyR0 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 |
| Conventional Radiotherapy | No intervention | –R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must provide written informed consent.
- 18 years old ≤ age <75 years old.
- 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.
- Masaoka⁃Koga ⁃ stage Ⅰ-Ⅲ
- ECOG performance status 0-2.
Key exclusion criteria (6 listed)
- patients with prior thoracic radiotherapy;
- diseases not suitable for radiotherapy, such as recent myocardial infarction, active congestive heart failure;
- Uncontrolled infectious disease or other serious medical or mental illness that may interfere with care
- Patients with other malignant tumors that are not under stable control;
- Known history of mental illness, substance abuse, alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Radiation TherapyR0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f | Radiation | Hypofractionated Radiotherapy |
Primary outcome
3-year PFS
Time frame: The patients were followed up for 3 years from enrollment to disease progression or death.
Time from enrollment to disease progression or death.
2 secondary outcomes
toxicity
Time frame: Patients were followed from enrollment until 3 years.
3-year OS
Time frame: The patients were followed up for 3 years from enrollment to death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy in people with Thymoma and Thymic Carcinoma and Thymoma, run by Rongrong Zhou 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Zhou, MD, PHD (+8613875898127, zhourr@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year PFS (time frame: The patients were followed up for 3 years from enrollment to disease progression or death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2024.