Cervical CarcinomaSTIRRNCT06804135
Systemic and Tumor Immune Response During Pelvic (Chemo)Radiation and/or Brachytherapy for Cervical Cancer
An observational study of Cervical Carcinoma, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Radiotherapy result in tumor cell death by creating an immune potentiation effect, but can also lead to long lasting immune suppression. Thus the investigators hypothesize that pelvic and/or para-aortic radiotherapy for cervical cancer affects local tumor immunity as well as systemic immune response that may be… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 25 Oct 2025to 30 Jan 2030
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients that are undergoing radiation treatment for primary radiation or reirradiation for cervical cancer.
Who may be able to join
- Common Inclusion Criteria:
- Age 18 years and above.
- Ability to tolerate full course of pelvic radiotherapy+/- chemotherapy +/- brachytherapy.
- Ability to understand and willingness to sign an informed consent document.
- Should be willing to undergo extra biopsies and blood samples collection for translational research study.
- Cohort A:
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- Patients diagnosed with LACC Stage IB2 - IIIC1, as per FIGO 2018 Classification for Radical Cohort.
- Stage IIIB-IVA where palliative RT is indicated for palliative cohort.
- No previous irradiation to the pelvis or chemo therapy.
- Cohort B:
- Patients diagnosed with LACC Stage IIIC2, as per FIGO 2018 Classification.
- No previous irradiation to the pelvis or chemotherapy.
- Cohort C:
- Patients diagnosed with gynecological cancer and presenting with need of infield radiation.
- Planned for reirradiation.
Who cannot join
- Severe medical condition impairing complete treatment delivery.
- Patients with immunocompromised states or active infection.
- Patients on immunosuppressive drugs for other medical conditions.
- Patients who will receive immune checkpoint inhibition (ICI) therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Supriya Sastri, MD, DNB
About this study
Official title: Systemic and Tumor Immune Response During Pelvic (Chemo)Radiation and/or Brachytherapy for Cervical Cancer (STIRR Cervix Study)
Radiotherapy result in tumor cell death by creating an immune potentiation effect, but can also lead to long lasting immune suppression. Thus the investigators hypothesize that pelvic and/or para-aortic radiotherapy for cervical cancer affects local tumor immunity as well as systemic immune response that may be instrumental for long term cancer cure. The goal of this observational study is to understand the effect of various radiotherapy dose per fraction, total dose and field volumes of radiation on systemic and tumor immune response in cervical cancer. The outcome of the study would be useful in improving the quality of radiation treatment and in reducing disease recurrence and improving survival in patients with cervical cancer.
Read the detailed description
This study will be performed using blood and tumor material at different time points and available information from blood tests that have been performed prior to initiating chemoradiation in the institution. The proposed sample size is 110 is a convenience based sampling that is based on estimate of people participating in the study during their radiotherapy course. Participants will be allotted in the cohort as per their radiation treatment plan. Collection of blood and tumor tissue material from participants will happen at different time points. These time points will be decided as per the cohort in whom the patient is. The study intends to investigate immunohistochemical (IHC) expression of PD-L1 on baseline and post-treatment tumor biopsy. Furthermore, the study will also investigate expression of immune cells through flow cytometry - fluorescence-activated cell sorter (FACS) at baseline and after RT on blood and tumor tissue sample. The study also intends to capture radiotherapy information - PTV Dose, HRCTV, Mean liver, spleen, Ileocecal junction dose, TRAK values. Using Analysis of Variance (ANOVA) test, all these parameters will be analyzed against their time points in the individual cohorts and also with other cohorts to provide us a better understanding of how pelvic radiotherapy affects our immune system. Furthermore, the investigators will also use Bonferroni correction test to account for multiple statistical comparison. Most of the research studies in cervical cancer that have been published till date do not utilize various aspects of radiotherapy like dose, dose per fraction, field volumes and techniques. This study will represent the first large cohort focusing on all the above mentioned aspects in cervical cancer patients.
- Conditions
- Cervical Carcinoma
- Keywords
- Cervical Cancer, Immune System, Radiotherapy, PD-L1 Expression
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Pelvic RT - Group 1 Radical Cohort | n=20 Fractionation Details = 45Gy/25# | |
| Cohort A - Group 2 Palliative Arm A | n=20 Fractionation Details = 25Gy/5# | |
| Cohort A - Group 3 Palliative Arm B | n=20 Fractionation Details = 30Gy/3# | |
| Cohort B Pelvic + Para aortic RT Group 4 | n=20 Fractionation Details = 45Gy/25# | |
| Cohort C Reirradiation Cohort - Group 5 Proton Therapy | n=10 Fractionation Details = 40Gy/20# | |
| Cohort C Reirradiation Cohort - Group 6 Photon Therapy | n=10 Fractionation Details = 25-30Gy/5-6# | |
| Cohort C Reirradiation Cohort - Group 7 SFRT | n=10 Fractionation Details = 45Gy/25# |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the systemic immune response in patients undergoing radiotherapy for cervical cancer.
To demonstrate correlation between radiation dose and volume \& systemic immune changes during radiotherapy.
Measured: 3 years
To study the multi-time point interaction between radiotherapy for cervical cancer and impact on tumor infiltrating immune cells and PD-L1 expression.
To demonstrate correlation between radiation dose and volume \& tumor immune changes during radiotherapy.
Measured: 3 years
Secondary outcomes (1)
To study 3-year disease free survival as a function of baseline and post radiotherapy immune cell composition.
To determine association of disease-free survival and clinical outcomes with baseline and post radiotherapy immune cell composition.
Measured: 3 years from last date of treatment and/or to date of reccurrence/relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start25 Oct 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804135
- Sponsor's protocol ID
- TMH IEC1 No 4591
- Acronym
- STIRR
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and Tumor Immune Response During Pelvic (Chemo)Radiation and/or Brachytherapy for Cervical Cancer (STIRR Cervix Study)
- ClinicalTrials.gov ID
- NCT06804135
- Acronym / sponsor ID
- STIRR / TMH IEC1 No 4591
- Conditions
- Cervical Carcinoma
- Keywords
- Cervical Cancer, Immune System, Radiotherapy, PD-L1 Expression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 3 Feb 2025 (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.
Radiotherapy result in tumor cell death by creating an immune potentiation effect, but can also lead to long lasting immune suppression. Thus the investigators hypothesize that pelvic and/or para-aortic radiotherapy for cervical cancer affects local tumor immunity as well as systemic immune response that may be instrumental for long term cancer cure. The goal of this observational study is to understand the effect of various radiotherapy dose per fraction, total dose and field volumes of radiation on systemic and tumor immune response in cervical cancer. The outcome of the study would be useful in improving the quality of radiation treatment and in reducing disease recurrence and improving survival in patients with cervical cancer.
Detailed description
This study will be performed using blood and tumor material at different time points and available information from blood tests that have been performed prior to initiating chemoradiation in the institution. The proposed sample size is 110 is a convenience based sampling that is based on estimate of people participating in the study during their radiotherapy course. Participants will be allotted in the cohort as per their radiation treatment plan. Collection of blood and tumor tissue material from participants will happen at different time points. These time points will be decided as per the cohort in whom the patient is. The study intends to investigate immunohistochemical (IHC) expression of PD-L1 on baseline and post-treatment tumor biopsy. Furthermore, the study will also investigate expression of immune cells through flow cytometry - fluorescence-activated cell sorter (FACS) at baseline and after RT on blood and tumor tissue sample. The study also intends to capture radiotherapy information - PTV Dose, HRCTV, Mean liver, spleen, Ileocecal junction dose, TRAK values. Using Analysis of Variance (ANOVA) test, all these parameters will be analyzed against their time points in the individual cohorts and also with other cohorts to provide us a better understanding of how pelvic radiotherapy affects our immune system. Furthermore, the investigators will also use Bonferroni correction test to account for multiple statistical comparison. Most of the research studies in cervical cancer that have been published till date do not utilize various aspects of radiotherapy like dose, dose per fraction, field volumes and techniques. This study will represent the first large cohort focusing on all the above mentioned aspects in cervical cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A Pelvic RT - Group 1 Radical Cohort | – | –n=20 Fractionation Details = 45Gy/25# |
| Cohort A - Group 2 Palliative Arm A | – | –n=20 Fractionation Details = 25Gy/5# |
| Cohort A - Group 3 Palliative Arm B | – | –n=20 Fractionation Details = 30Gy/3# |
| Cohort B Pelvic + Para aortic RT Group 4 | – | –n=20 Fractionation Details = 45Gy/25# |
| Cohort C Reirradiation Cohort - Group 5 Proton Therapy | – | –n=10 Fractionation Details = 40Gy/20# |
| Cohort C Reirradiation Cohort - Group 6 Photon Therapy | – | –n=10 Fractionation Details = 25-30Gy/5-6# |
| Cohort C Reirradiation Cohort - Group 7 SFRT | – | –n=10 Fractionation Details = 45Gy/25# |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients that are undergoing radiation treatment for primary radiation or reirradiation for cervical cancer.
Key inclusion criteria (15 listed)
- Common Inclusion Criteria:
- Patients diagnosed with LACC Stage IB2 - IIIC1, as per FIGO 2018 Classification for Radical Cohort.
- Stage IIIB-IVA where palliative RT is indicated for palliative cohort.
- No previous irradiation to the pelvis or chemo therapy.
- Patients diagnosed with LACC Stage IIIC2, as per FIGO 2018 Classification.
Key exclusion criteria (4 listed)
- Severe medical condition impairing complete treatment delivery.
- Patients with immunocompromised states or active infection.
- Patients on immunosuppressive drugs for other medical conditions.
- Patients who will receive immune checkpoint inhibition (ICI) therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the systemic immune response in patients undergoing radiotherapy for cervical cancer.
Time frame: 3 years
To demonstrate correlation between radiation dose and volume \& systemic immune changes during radiotherapy.
To study the multi-time point interaction between radiotherapy for cervical cancer and impact on tumor infiltrating immune cells and PD-L1 expression.
Time frame: 3 years
To demonstrate correlation between radiation dose and volume \& tumor immune changes during radiotherapy.
1 secondary outcome
To study 3-year disease free survival as a function of baseline and post radiotherapy immune cell composition.
Time frame: 3 years from last date of treatment and/or to date of reccurrence/relapse
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 4 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Carcinoma, run by Tata Memorial Hospital at 1 site 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 15 inclusion and 4 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Dr. Supriya Chopra (+022-68735000 ext. 5113, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the systemic immune response in patients undergoing radiotherapy for cervical cancer. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 4 Feb 2026.