Adjuvant treatment for thymoma or thymic carcinoma after incomplete surgery
A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma
This study is testing whether adding chemotherapy to radiation therapy can help people with thymoma or thymic carcinoma live longer after their surgery wasn't completely successful.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT02633514 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adjuvant radiochemotherapy compared to adjuvant radiotherapy in improving survival rates for patients with thymoma or thymic carcinoma who have undergone incomplete surgical resection. The trial aims to clarify the potential benefits of combining chemotherapy with radiotherapy in this patient population. Participants will receive treatments including Cisplatin, Etoposide, and radiotherapy within three months of their surgery. The study is designed to provide insights into optimal post-surgical treatment strategies for these rare cancers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed thymoma or thymic carcinoma who have undergone incomplete resection.
Not a fit: Patients with distant metastases or those who have previously received radiotherapy or chemotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with thymoma or thymic carcinoma following incomplete resection.
How similar studies have performed: Previous studies have shown that radiotherapy can prolong overall survival in these patients, but the combination of radiochemotherapy remains an area of ongoing investigation.
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 ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete 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
- Kailiang Wu — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Kailiang Wu, MD. PhD — Fudan University
- 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.