Adjuvant radiotherapy for thymoma after surgery
An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
This study is testing if adding radiation therapy after surgery can help people with stage II or III thymoma live longer and have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT02633553 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adjuvant radiotherapy in improving survival rates for patients with stage II or III thymoma following complete surgical resection. It aims to clarify the controversial benefits of radiotherapy in this patient population, as previous studies have shown that complete resection generally leads to better outcomes. The trial will enroll patients aged 18 to 75 who have undergone complete resection within the last three months and meet specific health criteria. Participants will receive adjuvant radiotherapy to assess its impact on their survival.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with pathologically confirmed stage II or III thymoma who have undergone complete surgical resection.
Not a fit: Patients with distant metastases, those who have received prior radiotherapy or chemotherapy, or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that adjuvant radiotherapy significantly improves survival rates for patients with stage II or III thymoma after surgery.
How similar studies have performed: While there have been studies on thymoma treatment, the specific approach of adjuvant radiotherapy after complete resection for stage II or III thymoma remains somewhat controversial and is not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent. Exclusion Criteria: Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Where this trial is running
Shanghai, Shanghai Municipality
- Kailiang Wu — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kailiang Wu, MD.PhD.
- Email: wukailiang@aliyun.com
- Phone: +86 64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.