Cervical CancerVIBENCT06394297
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)
A study testing SBRT in people with Cervical Cancer, run by Fundacao Champalimaud at 1 site in Portugal.
Trial summary
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Aug 2023to 4 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy
- Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- Pelvic MRI.
- MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.
- Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.
- Planning MRI with the applicator in place for the SBRT boost.
- Para-aortic metastatic nodes below L1-L2 are allowed.
- Study specific signed patient informed consent.
Who cannot join
- 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 paraaortic L1-L2 interspace.
- Previous pelvic or abdominal radiotherapy.
- Previous total or partial hysterectomy.
- Contra-indications to MRI.
- Severe psychiatric condition.
- Severe, active co-morbidity.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Champalimaud Foundation
Lisbon, 1400-038
Manuela Seixas, +351 9675289072, manuela.seixas@fundacaochampalimaud.pt
Maria Inês Antunes, MD
About this study
Official title: A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Read the detailed description
This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.
SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year.
The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.
- Conditions
- Cervical Cancer
- Being tested
- SBRT
- Keywords
- cervical cancer, Stereotactic body radiotherapy (SBRT), Stereotactic ablative body radiotherapy (SABR), Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called SABR
SBRT to reproduce HDR BT dose distribution in non-operated patients LACC
| Study group | Role | What they receive |
|---|---|---|
| SBRT for cervical cancer | Experimental | SBRT to LACC following whole pelvis external beam radiotherapy Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetric Feasibility of SBRT boost
Fulfillment of protocol dosimetrical endpoints and constraints
Measured: through study completion, an average of 3 year
reproducibility of SBRT boost
anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Measured: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Inter/intra fractional target motion
3D deviations recorded in CBCT images and electromagnetic recording
Measured: during the 15 minutes of treatment delivery time
Adverse Events
Treatment related side effects based on CTCAE V5.0
Measured: through study completion, an average of 3 years
Local control
Free from loco-regional relapse
Measured: through study completion, an average of 3 years
Secondary outcomes (3)
Quality of life metrics
Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30
Measured: through study completion, an average of 3 years
Quality of life metrics
Change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire N24
Measured: through study completion, an average of 3 years
Distant Relapse
Free from distant relapse
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start4 Aug 2023
- Primary completion4 Aug 2025 (estimated)
- Study completion4 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients enrolled in this study must have received or planned to receive 45 to 50 Gray in 25 fractions to pelvis with a simultaneous integrated boost (SIB) of 55 Gray in 25 fractions to metabolic active primary lesion and of 55 Gray in 25 fractions to 62.5 Gray in 25 fractions suspicious nodes of prior external beam radiation therapy. Following completion, patients will receive a boost of 28 Gray in 4 fractions using Image Guided Stereotactic Body Radiation Therapy techniques.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inês Antunes, Fundacao Champalimaud
- Investigators
- Carlo Greco, MD, Study director, Fundaçao Champalimaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394297
- Sponsor's protocol ID
- VIBE
- Acronym
- VIBE
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
- ClinicalTrials.gov ID
- NCT06394297
- Acronym / sponsor ID
- VIBE / VIBE
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, Stereotactic body radiotherapy (SBRT), Stereotactic ablative body radiotherapy (SABR), Brachytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 4 Aug 2025 (estimated)
- Study completion
- 4 Aug 2026 (estimated)
- First posted
- 1 May 2024 (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.
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Detailed description
This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.
SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year.
The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients enrolled in this study must have received or planned to receive 45 to 50 Gray in 25 fractions to pelvis with a simultaneous integrated boost (SIB) of 55 Gray in 25 fractions to metabolic active primary lesion and of 55 Gray in 25 fractions to 62.5 Gray in 25 fractions suspicious nodes of prior external beam radiation therapy. Following completion, patients will receive a boost of 28 Gray in 4 fractions using Image Guided Stereotactic Body Radiation Therapy techniques.
| Arm | Type | Receives |
|---|---|---|
| SBRT for cervical cancer | Experimental | Radiation: SBRTSBRT to LACC following whole pelvis external beam radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy
- Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- Pelvic MRI.
- MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.
- Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.
Key exclusion criteria (8 listed)
- 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 paraaortic L1-L2 interspace.
- Previous pelvic or abdominal radiotherapy.
- Previous total or partial hysterectomy.
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 |
|---|---|---|
| SBRTAlso: SABRSBRT to reproduce HDR BT dose distribution in non-operated patients LACC | Radiation | SBRT for cervical cancer |
Primary outcome
Dosimetric Feasibility of SBRT boost
Time frame: through study completion, an average of 3 year
Fulfillment of protocol dosimetrical endpoints and constraints
reproducibility of SBRT boost
Time frame: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Inter/intra fractional target motion
Time frame: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
Adverse Events
Time frame: through study completion, an average of 3 years
Treatment related side effects based on CTCAE V5.0
Local control
Time frame: through study completion, an average of 3 years
Free from loco-regional relapse
3 secondary outcomes
Quality of life metrics
Time frame: through study completion, an average of 3 years
Quality of life metrics
Time frame: through study completion, an average of 3 years
Distant Relapse
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carlo Greco, MD study director
Fundaçao Champalimaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Cervical Cancer, run by Fundacao Champalimaud at 1 site in Portugal.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Inês Antunes, MD (+351210480200, ines.antunes@fundacaochampalimaud.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetric Feasibility of SBRT boost (time frame: through study completion, an average of 3 year). The study lists 5 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 1 May 2024.