Cervix CancerPhase 2NCT02091050
2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy
A Phase 2 study testing 2D HDR planning and 3D HDR planning in people with Cervix Cancer and Endometrial Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial summary
Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cervix Cancer, Endometrial Cancer
- What is being tested?
- 2D HDR planning and 3D HDR planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Jan 2017
- Phase
- Phase 2
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant neoplasm of the cervix or endometrium;
- Tomography scan available in the planning system.
Who cannot join
- Patients did not undergo surgery as initial treatment;
- Patients without available tomography for planning;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.
Read the detailed description
Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .
Objective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.
Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units \& Measurements (ICRU 38).
- Conditions
- Cervix Cancer, Endometrial Cancer
- Being tested
- 2D HDR planning, 3D HDR planning
- Keywords
- 3D Brachytherapy, cervical cancer, endometrial cancer, vaginal vault brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D HDR planningOther
HDR planning using simple radiograph (2D)
3D HDR planningOther
HDR planning using computed tomography (3D)
| Study group | Role | What they receive |
|---|---|---|
| HDR Brachytherapy 24Gy (4 x 6Gy) | Other | Vaginal vault brachytherapy, associated or not with external beam radiotherapy. Receives: Other: 2D HDR planning; Other: 3D HDR planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry of Organs of genitourinary and gastrointestinal tracts
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.
Measured: one week after the tomograph
Secondary outcomes (5)
Cost analysis with local care.
Measured: 6 weeks
Acute Genitourinary Toxicity
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Measured: 6 weeks
Acute Gastrointestinal toxicity
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Measured: 6 weeks
Late Genitourinary Toxicity
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Measured: 3 Years
Late Gastrointestinal toxicity
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervix 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Gomes Sapienza, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091050
- Sponsor's protocol ID
- AC-G 01
- Status last verified
- Aug 2018
- First submitted
- 13 Mar 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sapienza LG, Flosi A, Aiza A, de Assis Pellizzon AC, Chojniak R, Baiocchi G. Volumetric (3D) bladder dose parameters are more reproducible than point (2D) dose parameters in vaginal vault high-dose-rate brachytherapy. Sci Rep. 2016 Jun 14;6:28074. doi: 10.1038/srep28074.
PubMed 27296459
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
- ClinicalTrials.gov ID
- NCT02091050
- Acronym / sponsor ID
- AC-G 01
- Conditions
- Cervix Cancer, Endometrial Cancer
- Keywords
- 3D Brachytherapy, cervical cancer, endometrial cancer, vaginal vault brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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.
Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.
Detailed description
Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .
Objective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.
Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units \& Measurements (ICRU 38).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDR Brachytherapy 24Gy (4 x 6Gy) | Other | Other: 2D HDR planning, Other: 3D HDR planningVaginal vault brachytherapy, associated or not with external beam radiotherapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Malignant neoplasm of the cervix or endometrium;
- Tomography scan available in the planning system.
Key exclusion criteria (2 listed)
- Patients did not undergo surgery as initial treatment;
- Patients without available tomography for planning;
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 |
|---|---|---|
| 2D HDR planningHDR planning using simple radiograph (2D) | Other | HDR Brachytherapy 24Gy (4 x 6Gy) |
| 3D HDR planningHDR planning using computed tomography (3D) | Other | HDR Brachytherapy 24Gy (4 x 6Gy) |
Primary outcome
Dosimetry of Organs of genitourinary and gastrointestinal tracts
Time frame: one week after the tomograph
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.
5 secondary outcomes
Cost analysis with local care.
Time frame: 6 weeks
Acute Genitourinary Toxicity
Time frame: 6 weeks
Acute Gastrointestinal toxicity
Time frame: 6 weeks
Late Genitourinary Toxicity
Time frame: 3 Years
Late Gastrointestinal toxicity
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Results publication: PubMed 27296459Sapienza LG, Flosi A, Aiza A, de Assis Pellizzon AC, Chojniak R, Baiocchi G. Volumetric (3D) bladder dose parameters are more reproducible than point (2D) dose parameters in vaginal vault high-dose-rate brachytherapy. Sci Rep. 2016 Jun 14;6:28074. doi: 10.1038/srep28074.
- Related InfoLink provided by the sponsor.
Related trials for Cervix Cancer
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2D HDR planning and 3D HDR planning in people with Cervix Cancer and Endometrial Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry of Organs of genitourinary and gastrointestinal tracts (time frame: one week after the tomograph). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091050, which also lists 1 linked publication.
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 31 Aug 2018.