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

ConditionCervical Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTata Memorial Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Group A: Cohort A Pelvic RT - Group 1 Radical Cohort
Group B: Cohort A - Group 2 Palliative Arm A
Group C: Cohort A - Group 3 Palliative Arm B
Group D: Cohort B Pelvic + Para aortic RT Group 4
Group E: Cohort C Reirradiation Cohort - Group 5 Proton Therapy
Group F: Cohort C Reirradiation Cohort - Group 6 Photon Therapy
Group G: Cohort C Reirradiation Cohort - Group 7 SFRT

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years
2

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.

Time frame
3 years

Secondary outcomes

1

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

To determine association of disease-free survival and clinical outcomes with baseline and post radiotherapy immune cell composition.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Hospital

Lead sponsor

Tata Memorial Centre

Sponsor institution

Source ClinicalTrials.gov
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