Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

NCT04016675 | Recruiting

• 1 other identifier: FD-EENT-20190701
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor of Lacrimal Drainage Structure

Outcome Measures

Primary Outcomes (12)

• overall survival at 2-year interval

  living subjects

  2 years

• overall survival at 5-year interval

  living subjects

  5 years

• overall survival at 10-year interval

  living subjects

  10 years

• disease-free survival at 2-year interval

  tumor-free subjects

  2 years

• disease-free survival at 5-year interval

  tumor-free subjects

  5 years

• disease-free survival at 10-year interval

  tumor-free subjects

  10 years

• distant metastasis-free survival at 2-year interval

  living subjects with no distant metastasis

  2 years

• distant metastasis-free survival at 5-year interval

  living subjects with no distant metastasis

  5 years

• distant metastasis-free survival at 10-year interval

  living subjects with no distant metastasis

  10 years

• locoregional control at 2-year interval

  living subjects without local recurrence or local metastasis

  2 years

• locoregional control at 5-year interval

  living subjects without local recurrence or local metastasis

  5 years

• locoregional control at 10-year interval

  living subjects without local recurrence or local metastasis

  10 years

Secondary Outcomes (6)

• Visual Acuity

  up to 2 years

• Subjective Diplopia After Surgery

  up to 2 years

• Number of Participants with Acute Radiation-Related Toxicity

  1 month

• Number of Participants with Chronic Radiation-Related Toxicity

  up to 2 years

• Health-Related Quality of life

  up to 10 years

Study Arms (2)

Study Group

EXPERIMENTAL

Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery

Other: Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery

Control Group

ACTIVE COMPARATOR

Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy

Other: Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy

Interventions

Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery OTHER

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.

Study Group

Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Zhongshan Ophthalmic Center, Sun Yat-sen University: collaborator
• Peking University Third Hospital: collaborator
• Tianjin Medical University Eye Hospital: collaborator
• Peking University Eye Center: collaborator

Study Sites (1)

Fudan Eye & ENT Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Jiang Qian, MD

  Fudan Eye & ENT Hospital

  STUDY CHAIR

Central Study Contacts

Jiang Qian, MD

CONTACT

+86 (021) 64377134; qianjiang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2035
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)