RecruitingNot ApplicableNCT04016675

Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

Long-term Outcomes of Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Malignant Lacrimal Sac Tumors (A Multicenter Randomized Controlled Trial)

Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

94 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Malignant Tumor of Lacrimal Drainage Structure

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the use of pre-operative (neoadjuvant) radiation therapy for treating malignant tumors of the lacrimal sac, which is a small structure in the inner corner of the eye that drains tears. These are very rare tumors, and this study aims to evaluate whether delivering radiation before surgery improves outcomes — reducing the risk of the cancer spreading during surgery and improving the chances of complete removal. Lacrimal sac tumors are difficult to treat because of their proximity to the eye, nose, and brain. Traditional surgery alone carries a risk of seeding cancer cells, especially for aggressive tumor types. Pre-operative radiation may shrink the tumor and sterilize the margins, making surgery safer and more effective. This study collects outcomes data to test this hypothesis. **You may be eligible if...** - You are between 18 and 80 years of age - You have been diagnosed with or are suspected to have a malignant lacrimal sac tumor based on symptoms, imaging, or biopsy - You have had prior minor procedures (e.g., silicone tube intubation, endoscopic DCR, biopsy) but not full surgical removal **You may NOT be eligible if...** - Your tumor has already been removed surgically - Your tumor has returned after prior treatment (recurrent) - Your tumor has spread to lymph nodes or distant sites (metastatic) - Your tumor type (e.g., lymphoma) requires non-surgical treatment - Your tumor is very large and invades more than two-thirds of the orbit, requiring full orbital removal **Talk to your doctor** about your diagnosis, imaging findings, and what prior procedures you have had to determine if this protocol is appropriate for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERNeoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery

After assigned into the study group, subjects will be conducted with incisional biopsy. Based on the tumor type and tumor stage, subjects will be conducted with neoadjuvant radiotherapy/chemoradiotherapy followed by radical surgery and simultaneous orbital reconstruction. After surgery, adjuvant chemotherapy will be determined based on the tumor histology, local tumor invasiveness, proximity of the surgical margins from the tumor, and pronouncement of tumor margins on permanent section tissue review.

OTHERSurgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy

After assignment into the control group, subjects will receive radical surgery without simultaneous orbital reconstruction. Adjuvant radiotherapy / chemoradiotherapy will initiate within two weeks after surgery. Both the radiotherapy and chemoradiotherapy should be comparable between the study group and the control group when tumor characteristics in these two groups are identical.

Locations(1)

Fudan Eye & ENT Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04016675