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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Study coordinator: Dr. Supriya Chopra
• Email: supriyasastri@gmail.com
• Phone: +022-68735000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.