Clinical trial NCT04016675: Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors
Official title: Long-term Outcomes of Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Malignant Lacrimal Sac Tumors (A Multicenter Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Tumor of Lacrimal Drainage Structure
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Peking University Third Hospital
name: Tianjin Medical University Eye Hospital
name: Peking University Eye Center
First posted: 2019-07-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: overall survival at 2-year interval
timeFrame: 2 years
measure: overall survival at 5-year interval
timeFrame: 5 years
measure: overall survival at 10-year interval
timeFrame: 10 years
measure: disease-free survival at 2-year interval
timeFrame: 2 years
measure: disease-free survival at 5-year interval
timeFrame: 5 years
measure: disease-free survival at 10-year interval
timeFrame: 10 years
measure: distant metastasis-free survival at 2-year interval
timeFrame: 2 years
measure: distant metastasis-free survival at 5-year interval
timeFrame: 5 years
measure: distant metastasis-free survival at 10-year interval
timeFrame: 10 years
measure: locoregional control at 2-year interval
timeFrame: 2 years
measure: locoregional control at 5-year interval
timeFrame: 5 years
measure: locoregional control at 10-year interval
timeFrame: 10 years
Secondary outcomes:
measure: Visual Acuity
timeFrame: up to 2 years
measure: Subjective Diplopia After Surgery
timeFrame: up to 2 years
measure: Number of Participants with Acute Radiation-Related Toxicity
timeFrame: 1 month
measure: Number of Participants with Chronic Radiation-Related Toxicity
timeFrame: up to 2 years
measure: Health-Related Quality of life
timeFrame: up to 10 years
measure: Ophthalmic Cancer-Related Quality of life
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Eye & ENT Hospital
Study officials:
affiliation: Fudan Eye & ENT Hospital
name: Jiang Qian, MD
role: STUDY_CHAIR
References: