Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03617133


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT03617133
Ethics application status
Date submitted
13/07/2018
Date registered
6/08/2018
Date last updated
17/03/2022

Titles & IDs
Public title
Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
Scientific title
Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer
Secondary ID [1] 0 0
EMBRACE 2
Universal Trial Number (UTN)
Trial acronym
EMBRACEII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT
* Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
* Staging according to FIGO and TNM guidelines
* MRI of pelvis at diagnosis is performed
* MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
* MRI with the applicator in place at the time of (first) BT will be performed
* Para-aortic metastatic nodes below L1-L2 are allowed
* Patient informed consent
Minimum age
18 Years
Maximum age
99 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
* Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
* Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace
* Previous pelvic or abdominal radiotherapy
* Previous total or partial hysterectomy
* Combination of preoperative radiotherapy with surgery
* Patients receiving BT only
* Patients receiving EBRT only
* Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy.
* Contra indications to MRI
* Contra indications to BT

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 2
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
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2031
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Medical University of Vienna
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The research group on adaptive image-guided radiotherapy for locally advanced cervical carcinoma completed the protocol for the EMBRACE II study in October 2018. This study will be carried out in the next few years at the University Clinic for Radiotherapy at the Medical University of Vienna and other international partner institutes. EMBRACE II builds on the findings of the current EMBRACE study. These are already implemented in everyday clinical practice in order to further improve the accuracy of the entire therapy of cervical carcinomas, using state-of-the-art techniques of tele- and brachytherapy. The aim of the EMBRACE II study is to maintain and enhance the excellent local tumor control as well as the nodal and systemic control for all tumor stages while minimizing the adverse reaction rates for all affected organs (rectum, sigmoid, urinary bladder, and vagina) to increase the quality of life of patients with cervical carcinomas.
Trial website
https://clinicaltrials.gov/study/NCT03617133
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Richard Pötter, MD
Address 0 0
Medical University of Vienna
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Richard Pötter, MD
Address 0 0
Country 0 0
Phone 0 0
0043140400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03617133

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11
Liverpool Hospital
Recruitment hospital [2] 12
Campbelltown Hospital
Recruitment postcode(s) [1] 11
2170
Recruitment postcode(s) [2] 12
2560
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
South Western Sydney Local Health District
Primary sponsor address
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 9
South Western Sydney Local Health District Human Research Ethics Committee
Address [1] 9
South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
Country [1] 9
Australia
Date submitted for ethics approval [1] 9
27/05/2019
Approval date [1] 9
25/06/2019
Ethics approval number [1] 9
2019/ETH00443
 
Public notes

Contacts
Principal investigator
Title 89 0
Dr
Name 89 0
Karen Lim
Address 89 0
South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
Country 89 0
Australia
Phone 89 0
+61 2 8738 9805
Fax 89 0
+61 2 8738 9819
Email 89 0
[email protected]
Contact person for public queries
Title 90 0
Ms
Name 90 0
Tess Afinidad
Address 90 0
South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
Country 90 0
Australia
Phone 90 0
+61 2 8738 9146
Fax 90 0
+61 2 8738 9205
Email 90 0
[email protected]
Contact person for scientific queries
Title 91 0
Dr
Name 91 0
Karen Lim
Address 91 0
South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
Country 91 0
Australia
Phone 91 0
+61 2 8738 9805
Fax 91 0
+61 2 8738 9819
Email 91 0
[email protected]