Neoadjuvant radiotherapy for malignant tumors in the lacrimal sac
Long-term Outcomes of Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Malignant Lacrimal Sac Tumors (A Multicenter Randomized Controlled Trial)
This study is testing if giving radiation therapy before surgery can help people with cancer in the lacrimal sac have better outcomes and lower the chances of the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04016675 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of neoadjuvant radiotherapy or chemoradiotherapy followed by surgery for patients with malignant lacrimal sac tumors. The innovative approach aims to reduce tumor size and encapsulate the tumor in a fibrotic cyst, facilitating en-bloc excision and simultaneous orbital reconstruction. By comparing long-term outcomes with traditional adjuvant radiotherapy, the study seeks to minimize recurrence and metastasis risks while lowering radiation exposure. The trial includes patients with suggestive symptoms and imaging features of malignant tumors, regardless of prior surgeries.
Who should consider this trial
Good fit: Ideal candidates are patients with symptoms and imaging results indicative of malignant lacrimal sac tumors, regardless of previous surgical interventions.
Not a fit: Patients with recurrent tumors, metastatic tumors, or those requiring non-surgical treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and reduce the risk of recurrence for patients with malignant lacrimal sac tumors.
How similar studies have performed: While the approach of neoadjuvant radiotherapy is innovative, similar strategies in other tumor types have shown promise, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suggestive symptoms, signs, imaging features and/or biopsy results for malignant lacrimal sac tumors * Regardless of previous operations including silicone tube intubation, endoscopic dacryocystorhinostomy and incisional/needle biopsy Exclusion Criteria: * Recurrent tumors * Metastatic tumors to the lacrimal sac region * Malignant lacrimal sac tumors with previous surgical excision * Malignant lacrimal sac tumors with local nodal or distant metastasis * Special tumor types (e.g. lymphoma) which require non-surgical treatment * Large tumors (invades ≥ 2/3 depth of the orbit) which require orbital exenteration
Where this trial is running
Shanghai
- Fudan Eye & ENT Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jiang Qian, MD
- Email: qianjiang@fudan.edu.cn
- Phone: +86 (021) 64377134
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.