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A multi-cohort study to evaluate Immune response of cervical cancer patients during radiotherapy.

Systemic and Tumor Immune Response during pelvic (chemo)Radiation and or brachytherapy for cervical cancer (STIRR Cervix Study) - STIRR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/083811
Enrollment
110
Registered
2025-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: Cohort A Pelvic RT - Group 1 Radical Cohort: n=20 Fractionation Details = 45Gy/25# Control Intervention2: Cohort A Pelvic RT - Group 2 Palliative Arm A:

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Common Inclusion Criteria 1. Age 18 years and above. 2. Ability to tolerate full course of pelvic radiotherapy and or chemotherapy and or brachytherapy 3. Ability to understand and willingness to sign an informed consent document. 4. Should be willing to undergo extra biopsies and blood samples collection for translational research study. Cohort A 1. Patients diagnosed with LACC Stage IB2 to IIIC1, as per FIGO 2018 Classification for Radical Cohort. 2. Stage IIIB to IVA where palliative RT is indicated for palliative cohort. 3. No previous irradiation to the pelvis or chemo therapy. Cohort B 1. Patients diagnosed with LACC Stage IIIC2, as per FIGO 2018 Classification. 2. No previous irradiation to the pelvis or chemotherapy. Cohort C 1. Patients diagnosed with gynecological cancer and presenting with need of infield radiation. 2. Planned for reirradiation.

Exclusion criteria

Exclusion criteria: 1. Severe medical condition impairing complete treatment delivery. 2. Patients with immunocompromised states or active infection. 3. Patients on immunosuppressive drugs for other medical conditions. 4. Patients who will receive immune checkpoint inhibition therapy.

Design outcomes

Primary

MeasureTime frame
Objective 1: To study the multi-time point interaction between radiotherapy for cervical cancer and impact on systemic immune cells. Objective 2: To study the multi-time point interaction between radiotherapy for cervical cancer and impact on tumor infiltrating immune cells and PD-L1 expression.Timepoint: Baseline, Week 1, Week 3, Month 3—

Secondary

MeasureTime frame
To study 3-year disease free survival as a function of baseline and post radiotherapy immune cell composition.Timepoint: 3 years from last day of treatment date and/or to date of recurrence/relapse.—

Countries

India

Contacts

Public ContactDr Supriya Chopra

Tata Memorial Centre

tanmay.wairkar@actrec.gov.in8879299557

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026