Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Malignant Tumor of Lacrimal Drainage Structure

Treatments: Other: Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery; Other: Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04016675

FD-EENT-20190701

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Study Group

Experimental group

Description:

Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery

Treatment:

Other: Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery

Control Group

Active Comparator group

Description:

Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy

Treatment:

Other: Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy