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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage IIIC
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes; Radiation: Standard Arm: Simultaneous Integrated Boost to involved pelvic node

Detailed Description

The goal of this observational study is to compare the safety profile of Stereotactic Body Radiotherapy Boost vs Simultaneous Integrated Boost to pelvic nodes among patients with Stage III-C carcinoma cervix by assessing the acute GI and GU toxicity (>Grade 3 GI/GU toxicity) within 30 days of completion of treatment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karun Kamboj, MD; Phone Number: 9416613389; Email: karunkamboj04@aiims.edu

Study Locations

• India
  • National Capital Territory of Delhi
    • Delhi, National Capital Territory of Delhi, India, 110049
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Karun Kamboj, MD; Phone Number: 9416613389; Email: karunkamboj04@aiims.edu
      • Contact: Email: karunkamboj04@aiims.edu
      • Principal Investigator: Karun Kamboj, MD
    • Delhi, National Capital Territory of Delhi, India, 110049
      • Recruiting
      • Karun Kamboj
      • Contact: Dr. KARUN KAMBOJ, MD; Phone Number: 9416613389; Email: karunkamboj04@aiims.edu
  • New Delhi
    • New Delhi, New Delhi, India, 110029
      • Recruiting
      • National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India
      • Contact: Karun Kamboj, MD; Phone Number: 4112 9416613389; Email: karunkamboj04@aiims.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with stage IIIC cervical cancer
2. No previous pelvic radiation therapy or surgery
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

1. Patients with stage I or stage II or stage IV disease.
2. Patients with prior malignancies or active autoimmune diseases
3. Uncontrolled medical comorbidity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Radiation: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes; Experimental Arm: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes Participants in the experimental arm will receive definitive radical chemoradiation for stage IIIC carcinoma cervix with a stereotactic body radiotherapy (SBRT) boost to the radiologically involved pelvic lymph node(s). The purpose of this intervention is to intensify the dose to gross nodal disease while maintaining acceptable doses to nearby organs at risk, including bowel, rectum, bladder, sigmoid, spinal cord, kidneys, femoral heads, duodenum, and active bone marrow. The SBRT boost is integrated with standard pelvic external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy as per institutional curative protocol.
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.	Radiation: Standard Arm: Simultaneous Integrated Boost to involved pelvic node; Patients in the standard arm will receive radical chemoradiation with pelvic external beam radiotherapy to 45 Gy in 25 fractions over 5 weeks, along with a simultaneous integrated boost to involved pelvic node(s) to 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. Concurrent weekly cisplatin 40 mg/m² will be administered during external beam radiotherapy, subject to adequate renal function and treatment tolerance. After completion of external beam treatment, patients will receive brachytherapy as per institutional protocol, using intracavitary or interstitial technique depending on residual disease and anatomy. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 3 or higher treatment-related adverse events	The primary outcome measure is the incidence of grade 3 or higher treatment-related adverse events, specifically acute gastrointestinal and genitourinary toxicity, assessed within 30 days of completion of treatment using CTCAE version 5.0.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 3 or higher acute gastrointestinal and genitourinary toxicity	Incidence of grade 3 or higher acute gastrointestinal and genitourinary toxicity, assessed at 6 months of completion of external-beam chemoradiation, using CTCAE version 5.0.	6 months
Dosimetric comparison	The dosimetric comparison of organs at risk during treatment planning.	6 months
Local control	The local control with clinical examination or radiologic response	6 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): November 19, 2025
• Study Completion (Estimated): November 19, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chemoradiation; Stereotactic Body Radiation Therapy; Simultaneous Integrated Boost
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: A-1087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No