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| Name | Class |
|---|---|
| Sohag University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | • 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of tumor size | Complete response , defined as the disappearance of all evidence of disease by physical examination and MRI pelvis | "up to 3 months " |
| Measure | Description | Time Frame |
|---|---|---|
| survival rates | survival rates including disease free survival, overall survival | " 2 years " |
| Degree of toxicity | early and late treatment toxicity |
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Inclusion Criteria:
• Pathological confirmation squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of the uterine cervix.
Exclusion Criteria:
• FIGO stage IA , FIGO stage and Distant metastatic disease or presence of other malignancy .
this study is gender based as it's aim is evaluation of image guided brachytherapy in management of cancer cervix which is disease limited to females .
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 8, 2024 | |
| Reset | Jun 28, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 8, 2024 | Jun 28, 2024 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| "through study completion, an average of 2 year" |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |