Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

Официальное название

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

Обзор

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.

Вмешательства

• Другое Neoadjuvant 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 re
• Другое Surgery 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.

Первичные конечные точки

• overall survival at 2-year interval [Срок оценки: 2 years]
• overall survival at 5-year interval [Срок оценки: 5 years]
• overall survival at 10-year interval [Срок оценки: 10 years]
• disease-free survival at 2-year interval [Срок оценки: 2 years]
• disease-free survival at 5-year interval [Срок оценки: 5 years]
• disease-free survival at 10-year interval [Срок оценки: 10 years]
• distant metastasis-free survival at 2-year interval [Срок оценки: 2 years]
• distant metastasis-free survival at 5-year interval [Срок оценки: 5 years]
• distant metastasis-free survival at 10-year interval [Срок оценки: 10 years]
• locoregional control at 2-year interval [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Visual Acuity [Срок оценки: up to 2 years]
• Subjective Diplopia After Surgery [Срок оценки: up to 2 years]
• Number of Participants with Acute Radiation-Related Toxicity [Срок оценки: 1 month]
• Number of Participants with Chronic Radiation-Related Toxicity [Срок оценки: up to 2 years]
• Health-Related Quality of life [Срок оценки: up to 10 years]
• Ophthalmic Cancer-Related Quality of life [Срок оценки: up to 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan Eye & ENT Hospital — Шанхай

Идентификаторы

NCT: NCT04016675 · FD-EENT-20190701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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