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临床试验/CTRI/2018/10/016102
CTRI/2018/10/016102招募中2 期

Image guided intensity modulated External beam radiochemotherapy and MRI based adaptive BRAchytherapy in locally advanced CErvical cancer EMBRACE II - EMBRACE-II

PGIMER0 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
2 期
状态
招募中
发起方
PGIMER

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.Cancer of the uterine cervix considered suitable for curative treatment with definite radio-chemo therapy including MRI guided brachytherapy
  • 2. Positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
  • 3.Staging according to FIGO and TNM guidelines.(Stage IB, IIA, IIB, IIIA, IIIB and IVA)
  • 4. MRI of pelvis at diagnosis is performed.
  • 5. MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed.
  • 6. MRI with applicator in place at time of (first) BT will be performed.
  • 7. Para-aortic metastatic nodes below L1-L2 are allowed.
  • 8. Patient informed consent.

排除标准

  • 1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
  • 2. Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix.
  • 3. Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace.
  • 4. Previous pelvic or abdominal radiotherapy.
  • 5. Previous total or partial hysterectomy.
  • 6. Combination of preoperative radiotherapy with surgery.
  • 7. Patient receiving brachytherapy only.
  • 8. Patient receiving external radiotherapy only.
  • 9. Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40mg/2).However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and paclitaxel (155mg/m2) is allowed according to the departmental policy.
  • 6. Contra indications to MRI.
  • 7.Contra indications to brachytherapy.

研究者

发起方
PGIMER

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