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Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor

ConditionsThymic Epithelial TumorRadiotherapy Side EffectCarbon Ion RadiotherayHeavy Ion Radiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJian Chen

About this trial

To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with stage II-IV (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiotherapy who had undergone radical surgery (R2 resection, visible residual tumor) and had a definite pathological diagnosis.

Sign informed consent.

Between the ages of 18 and 70.

ECOG general status score of 0-2.

Disqualifiers

Complicated with other malignant tumors that have not been controlled.

Have large quantity of pleural or pericardial effusion.

Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.

Chest radiation therapy or radioactive particle implantation history.

Trial design

Design model

Single group

Treatments tested in this trial

  • Carbon ion radiotherapy

    Radiation

    The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or cisplatin / carboplatin / loplatin / nedaplatin; docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.

  • combined with platinum-based regimen

    Other intervention

    combined with platinum-based regimen

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Study armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Disease progression-free survival rate

Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.

Time frame
From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
2

Incidence of Treatment-induced Adverse Events

Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.

Time frame
From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months.

Secondary outcomes

1

Local-progression free survival rate

Local-progression free survival rate was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up.

Time frame
From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.
2

Overall survival rate

Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up.

Time frame
From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.
3

Cause-specific survival rate

Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by thymus tumor treated in this study or the last follow-up.

Time frame
From date of radiotherapy started until the date of death caused by thymus tumor treated in this study , assessed up to 100 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jian Chen

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution

Source ClinicalTrials.gov
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