Image Guided Brachytherapy in Locally Advanced Cancer Cervix

NCT04767425 | Unknown

• 1 other identifier: ٍSoh-Med-21-02-02
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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) ± chemotherapy (ChT) , and to take advantage of its full potential.

Conditions

Cancer Cervix

Keywords

cancer cervix , brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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 "

Secondary Outcomes (2)

• survival rates

  " 2 years "

• Degree of toxicity

  "through study completion, an average of 2 year"

Study Arms (1)

Experimental

EXPERIMENTAL

Radiation: Brachytherapy

Interventions

Brachytherapy RADIATION

• 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy

Experimental

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: 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 .
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• FIGO stage IA , FIGO stage and Distant metastatic disease or presence of other malignancy .
• Presence of other comorbid disease that would affect patient survival

Sponsors & Collaborators

• Fatma Ahmed Abdelfatah Rikabe: lead
• Sohag University: collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of clinical oncology

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2024
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share