- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767425
Image Guided Brachytherapy in Locally Advanced Cancer Cervix
Implementation of Image Guided Brachytherapy in Treatment of Patients With Locally Advanced Cancer Cervix
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
• FIGO stage IA , FIGO stage and Distant metastatic disease or presence of other malignancy .
- Presence of other comorbid disease that would affect patient survival
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
|
• 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
"up to 3 months "
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival rates
Time Frame: " 2 years "
|
survival rates including disease free survival, overall survival
|
" 2 years "
|
Degree of toxicity
Time Frame: "through study completion, an average of 2 year"
|
early and late treatment toxicity
|
"through study completion, an average of 2 year"
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ٍSoh-Med-21-02-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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