Stage IIICNCT07585929
Stereotactic Body Radiotherapy Boost Versus Simultaneous Integrated Boost to Pelvic Nodes Among Patients Receiving Radical Chemoradiation in Carcinoma Cervix
A study testing Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes and Standard Arm: Simultaneous Integrated Boost to involved pelvic node in people with Stage IIIC, run by All India Institute of Medical Sciences at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stage IIIC
- What is being tested?
- Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes and Standard Arm: Simultaneous Integrated Boost to involved pelvic node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesIndia
- Study dates
- 20 Nov 2024to 19 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage IIIC cervical cancer
- No previous pelvic radiation therapy or surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Who cannot join
- Patients with stage I or stage II or stage IV disease.
- Patients with prior malignancies or active autoimmune diseases
- Uncontrolled medical comorbidity
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
All India Institute of Medical Sciences
Delhi, National Capital Territory of Delhi, 110049
KARUN KAMBOJ, MD, 9416613389, karunkamboj04@aiims.edu
karunkamboj04@aiims.edu
- Recruiting
Karun Kamboj
Delhi, National Capital Territory of Delhi, 110049
Dr. KARUN KAMBOJ, MD, 9416613389, karunkamboj04@aiims.edu
- Recruiting
National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India
New Delhi, New Delhi, 110029
Karun Kamboj, MD, 9416613389 ext. 4112, karunkamboj04@aiims.edu
About this study
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.
Read the 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.
- Conditions
- Stage IIIC
- Being tested
- Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes, Standard Arm: Simultaneous Integrated Boost to involved pelvic node
- Keywords
- Chemoradiation, Simultaneous Integrated Boost, Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph NodesRadiation
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 nodeRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Standard Arm: Simultaneous Integrated Boost to involved pelvic node |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 6 months
Dosimetric comparison
The dosimetric comparison of organs at risk during treatment planning.
Measured: 6 months
Local control
The local control with clinical examination or radiologic response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start20 Nov 2024
- Primary completion19 Nov 2025
- Study completion19 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIICStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karun Kamboj, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585929
- Sponsor's protocol ID
- A-1087
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy Boost Versus Simultaneous Integrated Boost to Pelvic Nodes Among Patients Receiving Radical Chemoradiation in Carcinoma Cervix
- ClinicalTrials.gov ID
- NCT07585929
- Acronym / sponsor ID
- A-1087
- Conditions
- Stage IIIC
- Keywords
- Chemoradiation, Simultaneous Integrated Boost, Stereotactic Body Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions) | Experimental | Radiation: Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph NodesThe 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. |
| Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes) | Active comparator | Radiation: Standard Arm: Simultaneous Integrated Boost to involved pelvic nodePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stage IIIC cervical cancer
- No previous pelvic radiation therapy or surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (3 listed)
- Patients with stage I or stage II or stage IV disease.
- Patients with prior malignancies or active autoimmune diseases
- Uncontrolled medical comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph NodesExperimental 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. | Radiation | Stereotactic Body Radiotherapy (SBRT) boost to involved pelvic lymph nodes (14 Gy in 2 fractions) |
| Standard Arm: Simultaneous Integrated Boost to involved pelvic nodePatients 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. | Radiation | Conventional nodal boost by Simultaneous Integrated Boost (SIB)to involved pelvic lymph nodes) |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy Boost to Involved Pelvic Lymph Nodes and Standard Arm: Simultaneous Integrated Boost to involved pelvic node in people with Stage IIIC, run by All India Institute of Medical Sciences at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KARUN KAMBOJ, MD (9416613389, karunkamboj04@aiims.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3 or higher treatment-related adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.