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

NCT06804135 | Recruiting DMC

• 1 other identifier: TMH IEC1 No 4591
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cervical Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 years

Secondary Outcomes (1)

• To study 3-year disease free survival as a function of baseline and post radiotherapy immune cell composition.

  3 years from last date of treatment and/or to date of reccurrence/relapse

Study Arms (7)

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#

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients that are undergoing radiation treatment for primary radiation or reirradiation for cervical cancer.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Specimen FFPE Tissue Specimen

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Dr. Supriya Chopra

CONTACT

+022-68735000; supriyasastri@gmail.com

Mr. Tanmay Wairkar

CONTACT

+918879299557; wairkartanmay@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)