Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000211561
Ethics application status
Approved
Date submitted
24/11/2023
Date registered
1/03/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Increased dose at parametrium using intensity modulated radiotherapy in locally advanced cervical cancer treated with 2D brachytherapy
Scientific title
The effect of parametrial simultaneous integrated boost on local control in locally advanced cervical cancer treated with 2D brachytherapy
Secondary ID [1] 311026 0
None
Universal Trial Number (UTN)
U1111-1300-7067
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 332143 0
Condition category
Condition code
Cancer 328866 328866 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parametrial simultaneous integrated boost via linear accelerator using intensity modulated radiotherapy or volumetric modulated arc therapy, is delineated by a radiation oncologist and planned by a medical physicist. Prior to treatment delivery performed by radiotherapists, the plan is evaluated by the radiation oncologist. Dose for parametrial simultaneous integrated boost is 55 Gray (Gy) in 25 fractions (5 fractions per week), concomitant with whole pelvic radiation with dose of 50Gy. During and after external beam radiotherapy, brachytherapy is performed with total dose of 7Gy times 4, weekly. The total treatment time should not be more than 56 days. All the treatments are delivered in radiotherapy unit, Vajira Hospital, Bangkok, Thailand. To assess or monitor adherence or fidelity to the intervention, audit of medical records by principal investigator and/or secondary investigator is done. If there is any protocol deviation, the issue will be discussed and informed to the subject(s) involved in order to maintain or improve fidelity.
Intervention code [1] 327476 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336664 0
Local control defined as no recurrence in vagina, cervix, uterus and parametrium
Timepoint [1] 336664 0
baseline, 3 years following end of treatment
Secondary outcome [1] 429267 0
Regional control defined as no recurrence of pelvic and paraaortic lymph node
Timepoint [1] 429267 0
baseline, 3 years following end of treatment
Secondary outcome [2] 429268 0
toxicity
Timepoint [2] 429268 0
baseline, 3 years following end of treatment
Secondary outcome [3] 431153 0
Distant control defined as no recurrence in any organs excluding local and regional recurrences
Timepoint [3] 431153 0
baseline, 3 years following end of treatment
Secondary outcome [4] 431154 0
overall survival
Timepoint [4] 431154 0
baseline, 3 years following end of treatment
Secondary outcome [5] 431155 0
cancer specific survival
Timepoint [5] 431155 0
baseline, 3 years following end of treatment
Secondary outcome [6] 431156 0
quality of life
Timepoint [6] 431156 0
baseline, 3 years following end of treatment
Secondary outcome [7] 432302 0
quality of life
Timepoint [7] 432302 0
baseline, 3 years following end of treatment

Eligibility
Key inclusion criteria
squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of uterine cervix FIGO stage IB3-IVa with/without inguinal node metastases aged at least 18 years ECOG 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-other primary malignancies except carcinoma in situ of cervix and basal cell carcinoma of skin -previous hysterectomy -previous pelvic or abdominal radiotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2024
Actual
28/03/2024
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
39
Accrual to date
28
Final
Recruitment outside Australia
Country [1] 25988 0
Thailand
State/province [1] 25988 0

Funding & Sponsors
Funding source category [1] 315288 0
Hospital
Name [1] 315288 0
Vajira hospital
Country [1] 315288 0
Thailand
Primary sponsor type
Hospital
Name
Vajira hospital
Address
681 Samsen Rd, Wachira Phayaban, Dusit District, Bangkok 10330
Country
Thailand
Secondary sponsor category [1] 317329 0
None
Name [1] 317329 0
Address [1] 317329 0
Country [1] 317329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314211 0
IRB Faculty of Medicine Vajira Hospital
Ethics committee address [1] 314211 0
Ethics committee country [1] 314211 0
Thailand
Date submitted for ethics approval [1] 314211 0
15/06/2023
Approval date [1] 314211 0
24/08/2023
Ethics approval number [1] 314211 0
115/66 E

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

Contacts
Principal investigator
Name 130798 0
Mr Aniwat Berpan
Address 130798 0
Vajira Hospital, 681 Samsen Rd, Wachira Phayaban, Dusit District, Bangkok 10330
Country 130798 0
Thailand
Phone 130798 0
+66817289207
Fax 130798 0
Email 130798 0
[email protected]
Contact person for public queries
Name 130799 0
Aniwat Berpan
Address 130799 0
Vajira Hospital, 681 Samsen Rd, Wachira Phayaban, Dusit District, Bangkok 10330
Country 130799 0
Thailand
Phone 130799 0
+66817289207
Fax 130799 0
Email 130799 0
[email protected]
Contact person for scientific queries
Name 130800 0
Aniwat Berpan
Address 130800 0
Vajira Hospital, 681 Samsen Rd, Wachira Phayaban, Dusit District, Bangkok 10330
Country 130800 0
Thailand
Phone 130800 0
+66817289207
Fax 130800 0
Email 130800 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• other researchers

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data of published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims in the study protocol

When can requests for individual participant data be made (start and end dates)?
From:
after the first publication of the study, without end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by emailing the principal investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.