跳至主要内容
临床试验/NCT06804135
NCT06804135招募中不适用

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

Tata Memorial Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
2
主要终点
To investigate the systemic immune response in patients undergoing radiotherapy for cervical cancer.

研究概览

简要总结

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.

详细描述

This study will be performed using blood and tumor material at different time points and available information from blood tests that have been performed prior to initiating chemoradiation in the institution. The proposed sample size is 110 is a convenience based sampling that is based on estimate of people participating in the study during their radiotherapy course. Participants will be allotted in the cohort as per their radiation treatment plan. Collection of blood and tumor tissue material from participants will happen at different time points. These time points will be decided as per the cohort in whom the patient is. The study intends to investigate immunohistochemical (IHC) expression of PD-L1 on baseline and post-treatment tumor biopsy. Furthermore, the study will also investigate expression of immune cells through flow cytometry - fluorescence-activated cell sorter (FACS) at baseline and after RT on blood and tumor tissue sample. The study also intends to capture radiotherapy information - PTV Dose, HRCTV, Mean liver, spleen, Ileocecal junction dose, TRAK values. Using Analysis of Variance (ANOVA) test, all these parameters will be analyzed against their time points in the individual cohorts and also with other cohorts to provide us a better understanding of how pelvic radiotherapy affects our immune system. Furthermore, the investigators will also use Bonferroni correction test to account for multiple statistical comparison. Most of the research studies in cervical cancer that have been published till date do not utilize various aspects of radiotherapy like dose, dose per fraction, field volumes and techniques. This study will represent the first large cohort focusing on all the above mentioned aspects in cervical cancer patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.
  • •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.
  • •Patients diagnosed with LACC Stage IIIC2, as per FIGO 2018 Classification.
  • •No previous irradiation to the pelvis or chemotherapy.
  • •Patients diagnosed with gynecological cancer and presenting with need of infield radiation.
  • •Planned for reirradiation.

排除标准

  • •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.

研究组 & 干预措施

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 A Pelvic RT - Group 1 Radical Cohort

n=20 Fractionation Details = 45Gy/25#

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#

结局指标

主要结局

To investigate the systemic immune response in patients undergoing radiotherapy for cervical cancer.

时间窗: 3 years

To demonstrate correlation between radiation dose and volume \& systemic immune changes during radiotherapy.

To study the multi-time point interaction between radiotherapy for cervical cancer and impact on tumor infiltrating immune cells and PD-L1 expression.

时间窗: 3 years

To demonstrate correlation between radiation dose and volume \& tumor immune changes during radiotherapy.

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Supriya Sastri (chopra)

Professor, Radiation Oncology

Tata Memorial Centre

研究点 (2)

Loading locations...

相似试验