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
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