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NCT Number: NCT07585929

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences, Delhi, National Capital Territory of Delhi, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of grade 3 or higher treatment-related adverse events

    Time frame: 30 days

    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.

Secondary outcomes

  1. Grade 3 or higher acute gastrointestinal and genitourinary toxicity

    Time frame: 6 months

    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.

  2. Dosimetric comparison

    Time frame: 6 months

    The dosimetric comparison of organs at risk during treatment planning.

  3. Local control

    Time frame: 6 months

    The local control with clinical examination or radiologic response

Study contacts

Contact information is provided by the study sponsor or research team.

KARUN KAMBOJ, MD

CONTACT

[email protected]

9416613389

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.