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临床试验/CTRI/2022/01/039495
CTRI/2022/01/039495招募中3 期

ELECTIVE PARA-AORTIC VS PELVIC ONLY IRRADIATION IN PELVIC NODE POSITIVE CERVICAL CANCER: AN OPEN LABELLED PHASE III RANDOMIZED STUDY [EPIC Study] - EPIC STUDY

Institutional Intramural Funds0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1) Biopsy proved cancer of Cervix uteri.
  • 2) Patients with Age more than 18 years or less than 80 years.
  • 3) With Squamous cell carcinoma, Adenocarcinoma, or Adeno-squamous carcinoma histology.
  • 4) Patients with FIGO 2018 Stage IIIC1/ TNM cT2b-4a cN1 M0 (Pelvic LN positive cervical cancer)
  • established on suitable radiological imaging with atleast one factor:
  • Tumor with parametrial invasion (TNM cT2b cN1 M0)
  • Tumor extending to lower third of vagina (TNM cT3a cN1 M0)
  • Tumor extending to pelvic wall and/or causing hydronephrosis or nonfunctioning kidney (TNM
  • Tumor invading the mucosa of the bladder or rectum (TNM cT4a cN1) with mucosal infiltration
  • 5) Amenable for Curative Intent treatment.
  • 6) Fit to receive concurrent chemotherapy.
  • 7) Suitable for Brachytherapy boost.
  • 8) Should not be contraindicated for MRI
  • 9) With Informed patient consent.

排除标准

  • 1) Patients age less than 18 years or more than 80 years.
  • 2) Patients with Significant Para-aortic LN metastasis and/or increased uptake in PET CECT at
  • 3) Patients with distant metastasis
  • 4) Previous history of Abdominal or Pelvic radiotherapy
  • 5) Previous history of partial or total hysterectomy
  • 6) Patients who received Neoadjuvant chemotherapy
  • 7) Contraindicated for MRI
  • 8) Severe medical condition impairing complete treatment delivery
  • 9) Patients with immunocompromised states and psychological illness
  • 10) Patients planned only either for EBRT, or Brachytherapy
  • 11) Pregnant and lactating women

研究者

发起方
Institutional Intramural Funds

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