Immune changes in tumors and blood during pelvic radiotherapy and brachytherapy for cervical cancer.

Systemic and Tumor Immune Response During Pelvic (Chemo)Radiation and/or Brachytherapy for Cervical Cancer (STIRR Cervix Study)

This project will test whether pelvic radiotherapy, with or without chemotherapy and brachytherapy, changes immune cells and PD-L1 levels in tumors and blood of people with cervical cancer.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Tata Memorial Hospital (Government)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Mumbai, Maharashtra)
• Trial ID: NCT06804135 on ClinicalTrials.gov

What this trial studies

This observational study follows about 110 patients undergoing pelvic and/or para‑aortic radiotherapy with or without chemotherapy and brachytherapy, grouped into cohorts by treatment intent and field (radical, palliative, nodal disease, and re‑irradiation). Researchers collect blood and tumor biopsies at baseline and prespecified on‑treatment and post‑treatment time points to measure PD‑L1 by immunohistochemistry and enumerate immune cell populations by flow cytometry (FACS). Detailed radiotherapy dosimetry parameters (PTV dose, HR‑CTV, mean liver and spleen dose, ileocecal dose, TRAK) are recorded for each patient. Data will be analyzed using ANOVA with Bonferroni correction to link dose, fractionation and field volumes with systemic and intratumoral immune changes.

Who should consider this trial

Good fit: Adults (≥18) with cervical cancer who can tolerate a full course of pelvic radiotherapy ± chemotherapy ± brachytherapy, agree to extra biopsies and blood draws, and fit the protocol's FIGO stage cohorts are appropriate candidates.

Not a fit: Patients unable to complete radiotherapy because of severe comorbidity, those unwilling to provide extra tissue or blood samples, and patients who have already had pelvic irradiation (except those planned for the re‑irradiation cohort) are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If results show clear immune patterns, clinicians could adjust radiation plans to protect immune function and potentially lower recurrence risk.

How similar studies have performed: Previous research has shown that radiation can alter tumor immune infiltrates and PD‑L1 expression but results are variable and clinical implications remain under study.

Eligibility criteria

Inclusion Criteria:

* Common Inclusion Criteria:

  1. Age 18 years and above.
  2. Ability to tolerate full course of pelvic radiotherapy+/- chemotherapy +/- 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 - IIIC1, as per FIGO 2018 Classification for Radical Cohort.
2. Stage IIIB-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:

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 (ICI) therapy.

Where this trial is running

Mumbai, Maharashtra

• Tata Memorial Centre — Mumbai, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: Dr. Supriya Chopra

Conditions Cervical Carcinoma; Cervical Cancer; Immune System; Radiotherapy; PD-L1 Expression