Health TrialsbyHealthPanel

Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

ConditionThymoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed type AB or B1-3 thymoma.

Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).

Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.

Between the ages of 18 and 70 years, regardless of sex.

Disqualifiers

Contraindications to Methylprednisolone.

History of or Concurrent Malignancy.

Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.

Pregnant or Lactating Women.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Hypofractionated radiotherapy

  • Concurrent chemotherapy

    Drug

    weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)

  • Methylprednisolone

    Drug

    Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Study armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy

Time frame
1-2 months after chemoradiotherapy

Secondary outcomes

1

Progression-free survival

From the start date of initial treatment to progression, death or last follow-up

Time frame
2-year
2

Overall survival

From the start date of initial treatment to death or to last follow-up.

Time frame
2-year
3

Toxicities using the CTCAE 5.0

Toxicities were evaluated using the CTCAE 5.0

Time frame
1 year after treatment
4

Quality of life scores

Quality of life assessed by QLQ-C30

Time frame
1 year after treatment

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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