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Recruiting NCT07585929

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

No phase Interventional Stage IIIC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes, Standard Arm: Simultaneous Integrated Boost to involved pelvic node.
Who it may be relevant to
Registry conditions: Stage IIIC. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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 co
  • 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

Primary outcome measures

  • Incidence of grade 3 or higher treatment-related adverse events [Time frame: 30 days]
Secondary outcome measures (3)
  • Grade 3 or higher acute gastrointestinal and genitourinary toxicity [Time frame: 6 months]
  • Dosimetric comparison [Time frame: 6 months]
  • Local control [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 3 centers
  • All India Institute of Medical Sciences — Delhi
  • Karun Kamboj — Delhi
  • National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India — New Delhi

Identifiers

NCT: NCT07585929 · A-1087

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗