Cancer CervixNCT04767425
Image Guided Brachytherapy in Locally Advanced Cancer Cervix
A study testing Brachytherapy in people with Cancer Cervix, run by Fatma Ahmed Abdelfatah Rikabe.
Trial summary
This is non comparative prospective interventional study with some areas for observational research to implement based image guided adaptive cervical cancer brachytherapy ( BT ) combined with Intensity Modulated Radiotherapy ( IMRT ) / Volumetric Modulated Arc Therapy ( VMAT) external beam radiotherapy (EBRT) ±… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cancer Cervix
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2024
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Pathological confirmation squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of the uterine cervix.
- Locally advanced cervical cancer , Federation of Gynecology and Obstetrics staging system FIGO stage IB ,FIGO stage IIA , FIGO stage IIB , FIGO stage IIIA, FIGO stage and FIGO stage IVA (and nodal status according to TNM) in whom definitive radio-chemotherapy with curative intent is planned are qualified for the study .
- No evidence of distant metastasis or other malignancy.
- No other comorbid disease that would affect patient survival
Who cannot join
- • FIGO stage IA , FIGO stage and Distant metastatic disease or presence of other malignancy .
- Presence of other comorbid disease that would affect patient survival
About this study
Official title: Implementation of Image Guided Brachytherapy in Treatment of Patients With Locally Advanced Cancer Cervix
This is non comparative prospective interventional study with some areas for observational research to implement based image guided adaptive cervical cancer brachytherapy ( BT ) combined with Intensity Modulated Radiotherapy ( IMRT ) / Volumetric Modulated Arc Therapy ( VMAT) external beam radiotherapy (EBRT) ± chemotherapy (ChT) , and to take advantage of its full potential.
Read the detailed description
- Eligible patients will receive both external beam radiotherapy ( EBRT) and concomitant chemotherapy and brachytherapy ( BT). Summation of EBRT and BT doses will be performed by calculation of a biologically equivalent dose in 2 Gy per fraction (EQD2) using the linear-quadratic model with α/β = 10 Gy for tumor effects and α/β = 3 Gy for late normal tissue damage. The repair half time is assumed to be 1.5 hrs.
- EBRT will be delivered as IMRT/VMAT with daily cone beam Computed Tomography ( CT ) Image Guided Radiotherapy (IGRT) in 25 fractions with 1.8 Gy to a total dose of 45 Gy given in 5 weeks.
- 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy , with ''Pre-radiotherapy Magnetic Resonance Imaging ( MRI ) examination'' to provide sufficient information about tumor extent in three dimension (3D) at the time of diagnosis and ''BT MRI examination'' is alse needed to provide sufficient information about tumor/target extent at the time of brachytherapy with the applicators in place .
For EBRT ; Using the cumulative Dose-volume histograms ( DVH ) to ensure that minimum dose to the target 95%, maximum dose limited to 107%, also, the dose to the organ at risk will be kept to the minimum according to the Radiation therapy oncology group ( RTOG ) recommendation.
For BT ; Dose volume adaptation will be performed with the aim of dose escalation in large tumors (prescribed D90 > 85 Gy , Dose volume constraints (D2cc) were 70-75 Gy for rectum and sigmoid and 90 Gy for bladder.
Differential DVH, the dose standard deviations will be used to asses dose homogeneity.
The conformity index and dose gradient measure will be calculated . Collection of data : Data will be collected by doctor himself in Excel sheet . Statistics : numerical Data will be reported with mean , median , standard deviation \& variance and represented with suitable graph like histograms and frequency polygon . Discrete data will be analyzed with suitable tests like Chi-square test \& fisher's exact test and will represented with suitable graph like pie graph .
Inferential statistics will be reported with 95 confidence interval \& A P-value <0.05 will be considered as statistically significant .
Survival analysis will be analyzed using the actuarial Kaplan Meier method , time will be calculated with date of diagnosis .
Data from patients who had not reached the endpoint at the time of last follow -up will be treated as censored observations
- Conditions
- Cancer Cervix
- Being tested
- Brachytherapy
- Keywords
- cancer cervix , 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.
BrachytherapyRadiation
- 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of tumor size
Complete response , defined as the disappearance of all evidence of disease by physical examination and MRI pelvis
Measured: "up to 3 months "
Secondary outcomes (2)
survival rates
survival rates including disease free survival, overall survival
Measured: " 2 years "
Degree of toxicity
early and late treatment toxicity
Measured: "through study completion, an average of 2 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CervixStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Ahmed Abdelfatah Rikabe
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Sponsor-investigator, Fatma Ahmed Abdelfatah Rikabe, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767425
- Sponsor's protocol ID
- ٍSoh-Med-21-02-02
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Image Guided Brachytherapy in Treatment of Patients With Locally Advanced Cancer Cervix
- ClinicalTrials.gov ID
- NCT04767425
- Acronym / sponsor ID
- ٍSoh-Med-21-02-02
- Conditions
- Cancer Cervix
- Keywords
- cancer cervix , brachytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fatma Ahmed Abdelfatah RikabeUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 23 Feb 2021 (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 is non comparative prospective interventional study with some areas for observational research to implement based image guided adaptive cervical cancer brachytherapy ( BT ) combined with Intensity Modulated Radiotherapy ( IMRT ) / Volumetric Modulated Arc Therapy ( VMAT) external beam radiotherapy (EBRT) ± chemotherapy (ChT) , and to take advantage of its full potential.
Detailed description
- Eligible patients will receive both external beam radiotherapy ( EBRT) and concomitant chemotherapy and brachytherapy ( BT). Summation of EBRT and BT doses will be performed by calculation of a biologically equivalent dose in 2 Gy per fraction (EQD2) using the linear-quadratic model with α/β = 10 Gy for tumor effects and α/β = 3 Gy for late normal tissue damage. The repair half time is assumed to be 1.5 hrs.
- EBRT will be delivered as IMRT/VMAT with daily cone beam Computed Tomography ( CT ) Image Guided Radiotherapy (IGRT) in 25 fractions with 1.8 Gy to a total dose of 45 Gy given in 5 weeks.
- 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy , with ''Pre-radiotherapy Magnetic Resonance Imaging ( MRI ) examination'' to provide sufficient information about tumor extent in three dimension (3D) at the time of diagnosis and ''BT MRI examination'' is alse needed to provide sufficient information about tumor/target extent at the time of brachytherapy with the applicators in place .
For EBRT ; Using the cumulative Dose-volume histograms ( DVH ) to ensure that minimum dose to the target 95%, maximum dose limited to 107%, also, the dose to the organ at risk will be kept to the minimum according to the Radiation therapy oncology group ( RTOG ) recommendation.
For BT ; Dose volume adaptation will be performed with the aim of dose escalation in large tumors (prescribed D90 > 85 Gy , Dose volume constraints (D2cc) were 70-75 Gy for rectum and sigmoid and 90 Gy for bladder.
Differential DVH, the dose standard deviations will be used to asses dose homogeneity.
The conformity index and dose gradient measure will be calculated . Collection of data : Data will be collected by doctor himself in Excel sheet . Statistics : numerical Data will be reported with mean , median , standard deviation \& variance and represented with suitable graph like histograms and frequency polygon . Discrete data will be analyzed with suitable tests like Chi-square test \& fisher's exact test and will represented with suitable graph like pie graph .
Inferential statistics will be reported with 95 confidence interval \& A P-value <0.05 will be considered as statistically significant .
Survival analysis will be analyzed using the actuarial Kaplan Meier method , time will be calculated with date of diagnosis .
Data from patients who had not reached the endpoint at the time of last follow -up will be treated as censored observations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: Brachytherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Pathological confirmation squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of the uterine cervix.
Key exclusion criteria (2 listed)
- • FIGO stage IA , FIGO stage and Distant metastatic disease or presence of other malignancy .
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 |
|---|---|---|
| Brachytherapy• 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy | Radiation | Experimental |
Primary outcome
Reduction of tumor size
Time frame: "up to 3 months "
Complete response , defined as the disappearance of all evidence of disease by physical examination and MRI pelvis
2 secondary outcomes
survival rates
Time frame: " 2 years "
Degree of toxicity
Time frame: "through study completion, an average of 2 year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Cancer Cervix
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
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
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.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy in people with Cancer Cervix, run by Fatma Ahmed Abdelfatah Rikabe.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Reduction of tumor size (time frame: "up to 3 months "). 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 23 Feb 2021.