NCT04016675 Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors
| NCT ID | NCT04016675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Malignant Tumor of Lacrimal Drainage Structure |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2019-09-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The treatment for malignant lacrimal sac tumors is difficult and the prognosis is poor. The conventional strategy is surgical resection followed by adjuvant radiotherapy with or without concurrent chemotherapy. This approach has many drawbacks including positive surgical margins due to large tumor size, distant metastasis due to intraoperative squeeze, and implant exposure due to high doses of radiation. In previous research, the investigators innovatively adopted neoadjuvant radiotherapy (or chemoradiotherapy) and withdrew radiotherapy after surgery. Preoperative radiotherapy can effectively reduce the tumor size and encapsulate the tumor in a fibrotic cyst, and therefore enables en-bloc excision of the tumor and simultaneous orbital reconstruction. This multidisciplinary approach can reduce the risk of recurrence and metastasis, lower the dose of radiation, and avoid implant exposure after reconstruction. In order to compare the long-term outcomes between neoadjuvant radiotherapy and conventional treatment approach, the investigators will prospectively recruit 94 patients with malignant lacrimal sac tumors and randomly assign these subjects into the study group (neoadjuvant radiotherapy, 47 cases) and the control group (conventional treatment, 47 cases). The primary outcomes include overall survival, disease-free survival, distant metastasis-free survival, and locoregional control at 2-year, 5-year and 10-year intervals. The secondary outcomes include ocular functions (visual acuity and diplopia, tear film stability and tear secretion, globe dystopia and motility, and corneal topography), acute and chronic radiation-related toxicity, cosmesis (medial canthal tendon dystopia and eyelid retraction), and assessment of quality of life.
Eligibility 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
Contact & Investigator
Jiang Qian, MD
STUDY CHAIR
Fudan Eye & ENT Hospital
Frequently Asked Questions
Who can join the NCT04016675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Malignant Tumor of Lacrimal Drainage Structure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04016675 currently recruiting?
Yes, NCT04016675 is actively recruiting participants. Contact the research team at qianjiang@fudan.edu.cn for enrollment information.
Where is the NCT04016675 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04016675 clinical trial?
NCT04016675 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Jiang Qian, MD at Fudan Eye & ENT Hospital. The trial plans to enroll 94 participants.