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

NCT07585929 | Active Not Recruiting

• 1 other identifier: A-1087
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage IIIC

Keywords

Chemoradiation; Simultaneous Integrated Boost; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Grade 3 or higher acute gastrointestinal and genitourinary toxicity

  6 months

• Dosimetric comparison

  6 months

• Local control

  6 months

Study Arms (2)

Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions)

EXPERIMENTAL

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

Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes)

ACTIVE COMPARATOR

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

Interventions

Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes RADIATION

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.

Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions)

Standard Arm: Simultaneous Integrated Boost to involved pelvic node RADIATION

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.

Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Karun Kamboj

Delhi, National Capital Territory of Delhi, 110049, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a non-randomized comparative study in patients with stage IIIC carcinoma of the cervix receiving radical chemoradiation. The trial compares two ways of delivering an extra dose (boost) to involved pelvic lymph nodes: 1. One group receives a stereotactic body radiotherapy (SBRT) boost (14 Gy in 2 fractions) to the involved nodes, 2. The other group receives a conventional simultaneous integrated boost (SIB) (55-57.5 Gy in 25 fractions) to the same nodes. All patients receive standard pelvic external-beam radiotherapy (45 Gy in 25 fractions) with concurrent weekly cisplatin, followed by brachytherapy as per institutional protocol. The main goal is to compare the safety of these two approaches by measuring the incidence of grade 3 or higher acute gastrointestinal and genitourinary toxicity within 30 days of completing treatment, using CTCAE version 5.0.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 14, 2026
• Study Start: November 20, 2024
• Primary Completion: November 19, 2025
• Study Completion (Estimated): November 19, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)