Malignant Tumor of Lacrimal Drainage StructureNCT04016675
Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors
A study testing Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery and Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy in people with Malignant Tumor of Lacrimal Drainage Structure, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor of Lacrimal Drainage Structure
- What is being tested?
- Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery and Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term Outcomes of Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Malignant Lacrimal Sac Tumors (A Multicenter Randomized Controlled Trial)
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.
- Being tested
- Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery, Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by SurgeryOther
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.
Surgery Followed by Adjuvant Radiotherapy/ChemoradiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery Receives: Other: Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery |
| Control Group | Active comparator | Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy Receives: Other: Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival at 2-year interval
living subjects
Measured: 2 years
overall survival at 5-year interval
living subjects
Measured: 5 years
overall survival at 10-year interval
living subjects
Measured: 10 years
disease-free survival at 2-year interval
tumor-free subjects
Measured: 2 years
disease-free survival at 5-year interval
tumor-free subjects
Measured: 5 years
disease-free survival at 10-year interval
tumor-free subjects
Measured: 10 years
distant metastasis-free survival at 2-year interval
living subjects with no distant metastasis
Measured: 2 years
distant metastasis-free survival at 5-year interval
living subjects with no distant metastasis
Measured: 5 years
distant metastasis-free survival at 10-year interval
living subjects with no distant metastasis
Measured: 10 years
locoregional control at 2-year interval
living subjects without local recurrence or local metastasis
Measured: 2 years
locoregional control at 5-year interval
living subjects without local recurrence or local metastasis
Measured: 5 years
locoregional control at 10-year interval
living subjects without local recurrence or local metastasis
Measured: 10 years
Secondary outcomes (6)
Visual Acuity
Best-corrected visual acuity (BCVA) will be measured under standardized lighting conditions in the room, and will be converted to logarithm of the minimum angle of resolution (logMAR) values for statistical analysis.
Measured: up to 2 years
Subjective Diplopia After Surgery
Subjective diplopia will be assessed by categorizing patients according to four grades: no diplopia (absent), diplopia when the patient is tired or awakening (intermittent), diplopia at extremes of gaze (inconstant), and continuous diplopia in the primary or reading position (constant). A change of one grade is considered to be clinically relevant.
Measured: up to 2 years
Number of Participants with Acute Radiation-Related Toxicity
Acute radiation-related toxicity is defined as events occurring within 1 month after start of radiotherapy, and will be prospectively graded by the treating radiation oncologist according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5).
Measured: 1 month
Number of Participants with Chronic Radiation-Related Toxicity
Chronic radiation-related toxicity is defined as events occurring or persisting > 3 months after start of radiotherapy, and will be prospectively graded by the treating radiation oncologist according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5).
Measured: up to 2 years
Health-Related Quality of life
The health-related quality of life will be assessed based on the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core 30 (QLQ-C30) downloaded from https://www.eortc.org. This 30-item questionnaire includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. The multi-item scales include a different set of items. Each item includes four subscales, namely "Not at all" (1 point), "A little" (2 points), "Quite a bit" (3 points) and "Very much" (4 points).
The score will be recorded during each follow-up, and data will be analyzed for comparison between the study group and the control group.
Measured: up to 10 years
Ophthalmic Cancer-Related Quality of life
The ophthalmic cancer-related quality of life will be assessed based on the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Ophthalmic Cancer Module 30 (QLQ-OPT30) downloaded from https://www.eortc.org. The QLQ-OPT30 comprises of 30 questions assessing vision impairment (9 items), functional problems due to vision impairment (8 items), eye symptoms (6 items), worry about recurrent disease (2 items), problems with appearance (1 items), problems driving (2 items), headache (1 item), problems reading (1 item). Each item includes four subscales, namely "Not at all" (1 point), "A little" (2 points), "Quite a bit" (3 points) and "Very much" (4 points).
The score will be recorded during each follow-up, and data will be compared between the study group and the control group.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of Lacrimal Drainage StructureStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University, Peking University Third Hospital, Tianjin Medical University Eye Hospital, Peking University Eye Center
- Responsible party
- Principal investigator, Jiang Qian, Eye & ENT Hospital of Fudan University
- Investigators
- Jiang Qian, MD, Study chair, Fudan Eye & ENT Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016675
- Sponsor's protocol ID
- FD-EENT-20190701
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Malignant Lacrimal Sac Tumors (A Multicenter Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04016675
- Acronym / sponsor ID
- FD-EENT-20190701
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University, Peking University Third Hospital, Tianjin Medical University Eye Hospital, Peking University Eye Center
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by SurgeryNeoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery |
| Control Group | Active comparator | Other: Surgery Followed by Adjuvant Radiotherapy/ChemoradiotherapySurgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by SurgeryAfter 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 | Study Group |
| Surgery Followed by Adjuvant Radiotherapy/ChemoradiotherapyAfter 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. | Other | Control Group |
Primary outcome
overall survival at 2-year interval
Time frame: 2 years
living subjects
overall survival at 5-year interval
Time frame: 5 years
living subjects
overall survival at 10-year interval
Time frame: 10 years
living subjects
disease-free survival at 2-year interval
Time frame: 2 years
tumor-free subjects
disease-free survival at 5-year interval
Time frame: 5 years
tumor-free subjects
disease-free survival at 10-year interval
Time frame: 10 years
tumor-free subjects
distant metastasis-free survival at 2-year interval
Time frame: 2 years
living subjects with no distant metastasis
distant metastasis-free survival at 5-year interval
Time frame: 5 years
living subjects with no distant metastasis
distant metastasis-free survival at 10-year interval
Time frame: 10 years
living subjects with no distant metastasis
locoregional control at 2-year interval
Time frame: 2 years
living subjects without local recurrence or local metastasis
locoregional control at 5-year interval
Time frame: 5 years
living subjects without local recurrence or local metastasis
locoregional control at 10-year interval
Time frame: 10 years
living subjects without local recurrence or local metastasis
6 secondary outcomes
Visual Acuity
Time frame: up to 2 years
Subjective Diplopia After Surgery
Time frame: up to 2 years
Number of Participants with Acute Radiation-Related Toxicity
Time frame: 1 month
Number of Participants with Chronic Radiation-Related Toxicity
Time frame: up to 2 years
Health-Related Quality of life
Time frame: up to 10 years
Ophthalmic Cancer-Related Quality of life
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Qian, MD study chair
Fudan Eye & ENT Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery and Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy in people with Malignant Tumor of Lacrimal Drainage Structure, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Qian, MD (+86 (021) 64377134, qianjiang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival at 2-year interval (time frame: 2 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.