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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Common Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (1)

Tata Memorial Centre
Mumbai, Maharashtra, India