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Stereotactic Body Radiotherapy Boost Versus Simultaneous Integrated Boost to Pelvic Nodes Among Patients Receiving Radical Chemoradiation in Carcinoma Cervix

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cervical cancer is a significant cause of morbidity and mortality among women worldwide. Radiotherapy, in combination with chemotherapy or as a standalone treatment, is an effective treatment option for cervical cancer. However, traditional radiotherapy has its limitations, such as the potential for damage to surrounding healthy tissues. Stereotactic Body RadioTherapy (SBRT) is a newer radiotherapy technique that delivers high doses of radiation to the tumor with minimal damage to the surrounding tissues. This study aims to evaluate the safety of Stereotactic Body RadioTherapy to involved node in cervical cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients with stage IIIC cervical cancer

• No previous pelvic radiation therapy or surgery

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Locations
Other Locations
India
All India Institute of Medical Sciences
RECRUITING
Delhi
Karun Kamboj
RECRUITING
Delhi
National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India
RECRUITING
New Delhi
Contact Information
Primary
KARUN KAMBOJ, MD
karunkamboj04@aiims.edu
9416613389
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2026-11-19
Participants
Target number of participants: 150
Treatments
Experimental: Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions)
The experimental arm Stereotactic Body Radiotherapy (SBRT) boost regimen will consist of two fractions of 700 cGy each total of 14Gy in 2 fractions, delivered at 1st and 2nd week of the treatment.In the proposed protocol, the pelvic field dose will be delivered as 45 Gy in 25 fractions, while the nodal boost will be delivered as SBRT 14 Gy in 2 fractions, typically at the first and second weeks of treatment, subject to plan evaluation and organ-at-risk constraints. This sequencing is consistent with the concept of combining broad pelvic coverage with ablative focal escalation.~Patients will be immobilized supine with an abdominopelvic thermoplastic shell, and simulation will be performed using contrast-enhanced planning CT with MRI and PET-CT fusion where available. Bladder and bowel preparation will be standardized before simulation and treatment to improve reproducibility and reduce interfraction variation.
Active_comparator: Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes)
Patients in the standard arm will receive conventional radical chemoradiation for locally advanced carcinoma cervix with pelvic external beam radiotherapy and concurrent weekly cisplatin, followed by brachytherapy. Pelvic radiotherapy will be delivered to a dose of 45 Gy in 25 fractions over 5 weeks, using IMRT/VMAT or fixed-field technique, with standard contouring of elective pelvic target volumes and gross disease. The nodal boost will be delivered as a conventional Simultaneous Integrated Boost (SIB) to the involved pelvic node(s) during the course of external beam radiotherapy. A total dose of 55 Gy or 57.5 Gy in 25 fractions, delivered in a simultaneous integrated manner according to nodal size, location, and institutional planning constraints. Treatment will be planned with appropriate image guidance, and organs at risk will be respected according to predefined dose constraints. Toxicity will be monitored during treatment and follow-up, and graded using CTCAE version 5.0.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences

This content was sourced from clinicaltrials.gov