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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

⁃ 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.

Locations
Other Locations
India
Tata Memorial Centre
RECRUITING
Mumbai
Contact Information
Primary
Dr. Supriya Chopra
supriyasastri@gmail.com
+022-68735000
Backup
Mr. Tanmay Wairkar
wairkartanmay@yahoo.com
+918879299557
Time Frame
Start Date: 2025-10-25
Estimated Completion Date: 2030-01
Participants
Target number of participants: 110
Treatments
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#
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Hospital

This content was sourced from clinicaltrials.gov