Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

  • End date
    Dec 31, 2035
  • participants needed
  • sponsor
    Eye & ENT Hospital of Fudan University
Updated on 23 April 2022


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.

Condition Malignant Tumor of Lacrimal Drainage Structure
Treatment Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery, Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy
Clinical Study IdentifierNCT04016675
SponsorEye & ENT Hospital of Fudan University
Last Modified on23 April 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note