Stage IIIC
Conditions
Keywords
Chemoradiation, Simultaneous Integrated Boost, Stereotactic Body Radiation Therapy
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.
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
RADIATIONStereotactic 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.
RADIATIONStandard 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.
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 3 or higher treatment-related adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Grade 3 or higher acute gastrointestinal and genitourinary toxicity | 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. |
| Dosimetric comparison | 6 months | The dosimetric comparison of organs at risk during treatment planning. |
| Local control | 6 months | The local control with clinical examination or radiologic response |
Countries
India
Contacts
CONTACTKARUN KAMBOJ, MD
Outcome results
None listed