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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04073706




Registration number
NCT04073706
Ethics application status
Date submitted
26/08/2019
Date registered
29/08/2019

Titles & IDs
Public title
Sentinel Node Biopsy in Endometrial Cancer
Scientific title
A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer
Secondary ID [1] 0 0
ENDO-3
Universal Trial Number (UTN)
Trial acronym
ENDO-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer Stage I 0 0
Sentinel Lymph Node 0 0
Surgery 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - TH BSO with SNB Note: If participants (=45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Treatment: Surgery - TH BSO without retroperitoneal node dissection Note: If participants (=45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted

Experimental: TH BSO with SNB - Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) with Sentinel Node Biopsy (SNB) using Indocyanine Green (ICG)+/- Methylene Blue Dye (+/- omentectomy in high risk cell types) Note: If participants (=45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.

Active comparator: TH BSO without retroperitoneal node dissection - Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) without retroperitoneal node dissection (+/- omentectomy in high risk cell types) Note: If participants (=45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.


Treatment: Surgery: TH BSO with SNB Note: If participants (=45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) +/- Methylene Blue Dye is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the "sentinel node". These one or two nodes are thought to be first involved with cancer spread.

Treatment: Surgery: TH BSO without retroperitoneal node dissection Note: If participants (=45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries without retroperitoneal node dissection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1: Return to usual activities
Timepoint [1] 0 0
12 months from surgery
Primary outcome [2] 0 0
Stage 2: Disease Free Survival
Timepoint [2] 0 0
4.5 years from surgery
Secondary outcome [1] 0 0
Cost Effectiveness using QALYs using EuroQoL-5D (EQ-5D) Questionnaire
Timepoint [1] 0 0
12 months from surgery
Secondary outcome [2] 0 0
Cost Effectiveness measuring Intervention costs
Timepoint [2] 0 0
12 months from surgery
Secondary outcome [3] 0 0
Cost Effectiveness measuring GP and specialist consultations
Timepoint [3] 0 0
12 months from surgery
Secondary outcome [4] 0 0
Cost Effectiveness measuring radiology and imaging requirements
Timepoint [4] 0 0
12 months from surgery
Secondary outcome [5] 0 0
Cost Effectiveness measuring prescriptions and over the counter medicine requirements
Timepoint [5] 0 0
12 months from surgery
Secondary outcome [6] 0 0
Cost Effectiveness measuring community and health service requirements and days off work and informal care required by family and friends using a combination of the Health Services Questionnaire and clinical files
Timepoint [6] 0 0
12 months from surgery
Secondary outcome [7] 0 0
Cost Effectiveness: direct costs using a bottom-up approach by recording the volume of resource use in both groups of the trial, and then applying a unit cost to each component
Timepoint [7] 0 0
12 months from surgery
Secondary outcome [8] 0 0
Perioperative Outcomes: Adverse Events
Timepoint [8] 0 0
12 months from surgery
Secondary outcome [9] 0 0
Perioperative Outcomes: Length of Surgery
Timepoint [9] 0 0
At time of surgery
Secondary outcome [10] 0 0
Perioperative Outcomes: Blood Loss during Surgery
Timepoint [10] 0 0
At time of surgery
Secondary outcome [11] 0 0
Perioperative Outcomes: Blood Transfusion Requirements during Surgery
Timepoint [11] 0 0
At time of surgery
Secondary outcome [12] 0 0
Perioperative Outcomes: Length of Hospital Stay
Timepoint [12] 0 0
At time of discharge from hospital following surgery
Secondary outcome [13] 0 0
Health Related Quality of Life and Fear of Recurrence
Timepoint [13] 0 0
12 months from surgery
Secondary outcome [14] 0 0
Incidence of Lymphedema
Timepoint [14] 0 0
12 months from surgery
Secondary outcome [15] 0 0
Adjuvant Treatment Requirements
Timepoint [15] 0 0
12 months from surgery
Secondary outcome [16] 0 0
Value of Molecular Biomarkers
Timepoint [16] 0 0
24 months from surgery
Secondary outcome [17] 0 0
Value of Molecular Biomarkers
Timepoint [17] 0 0
12 months from surgery
Secondary outcome [18] 0 0
Value of Molecular Biomarkers
Timepoint [18] 0 0
12 months from surgery
Secondary outcome [19] 0 0
Value of Molecular Biomarkers
Timepoint [19] 0 0
12 months from surgery
Secondary outcome [20] 0 0
Value of Molecular Biomarkers
Timepoint [20] 0 0
12 months from surgery
Secondary outcome [21] 0 0
Overall Survival
Timepoint [21] 0 0
4.5 years from surgery
Secondary outcome [22] 0 0
Patterns of Recurrence - date and localization of 1st recurrence
Timepoint [22] 0 0
4.5 years from surgery
Secondary outcome [23] 0 0
Impact of body composition (sarcopenia) on surgical complications, recovery and overall survival
Timepoint [23] 0 0
4.5 years from surgery
Secondary outcome [24] 0 0
Impact of frailty on surgical complications, recovery and overall survival
Timepoint [24] 0 0
4.5 years from surgery
Secondary outcome [25] 0 0
Follow-Up Strategies
Timepoint [25] 0 0
4.5 years from surgery

Eligibility
Key inclusion criteria
1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);
2. Clinically stage I disease (disease confined to body of uterus);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Signed written informed consent;
5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)
6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease
7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is <45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).
8. Negative (serum or urine) pregnancy test = 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging.
2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (>1 cm) on medical imaging;
3. Estimated life expectancy of less than 6 months;
4. Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy;
5. Patients who have previously received radiation treatment to the pelvis
6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
7. Patient compliance and geographic proximity that do not allow adequate follow-up;
8. Patients with allergy to Indocyanine Green (ICG)
9. Patients who have had previous retroperitoneal surgery
10. Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph node dissection (lymphadenectomy)
11. Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu
12. Uterine perforation during endometrial tissue sampling

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2031
Actual
Sample size
Target
760
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [4] 0 0
Buderim Private Hospital - Buderim
Recruitment hospital [5] 0 0
North West Private Hospital - Everton Park
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [8] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [9] 0 0
St Andrews War Memorial Hospital - Spring Hill
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [12] 0 0
Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4556 - Buderim
Recruitment postcode(s) [5] 0 0
4053 - Everton Park
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
4000 - Spring Hill
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
India
State/province [3] 0 0
Delhi
Country [4] 0 0
Italy
State/province [4] 0 0
Via Pozzuolo
Country [5] 0 0
Singapore
State/province [5] 0 0
NUH Zone B

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermiar, MD
Address 0 0
Director, Queensland Centre for Gynaecological Cancer Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vanessa Behan, BSN
Address 0 0
Country 0 0
Phone 0 0
+61 7 3346 5590
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04073706