Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

NARecruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2035

Conditions
Malignant Tumor of Lacrimal Drainage Structure
Interventions
OTHER

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 review.

OTHER

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.

Trial Locations (1)

Unknown

RECRUITING

Fudan Eye & ENT Hospital, Shanghai

All Listed Sponsors
collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

collaborator

Peking University Third Hospital

OTHER

collaborator

Tianjin Medical University Eye Hospital

OTHER

collaborator

Peking University Eye Center

OTHER

lead

Eye & ENT Hospital of Fudan University

OTHER