NL-OMON55839招募中3 期
Phase III Randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy: OVHIPEC-2 - OVHIPEC-2
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. signed and written informed consent
- •2. age >=18
- •3. histological proven FIGO stage III primary epithelial ovarian, fallopian
- •tube, or extra-ovarian
- •cancer, treated with primary complete cytoreduction, or primary
- •cytoreduction with no more than
- •2.5 mm residual disease
- •a. in case of extra-abdominal enlarged lymph nodes, representative
- •cytology/histology or FDG-
- •PET scan must be negative;
- •b. resectable, local bowel involvement, iatrogenic abdominal wall
- •metastases or umbilical lesions are allowed;
- •c. in case no histological proof is available before surgery, patients can
- •be randomized during
- •surgery based on histological proof on intraoperative frozen section
- •4. fit for major surgery, WHO performance status 0-2
- •5. adequate bone marrow function, hepatic function and renal function
- •6. baseline health-outcome questionnaire should be completed before
- •randomization
- •7. able to understand the patient information and questionnaires.
排除标准
- •1. history of previous malignancy treated with chemotherapy
- •2. history of previous malignancy within five years prior to inclusion, with
- •the exception of carcinoma
- •in situ, radically excised basal cell or squamous cell cancer of the skin
- •or synchronal
- •endometrial carcinoma FIGO IA G1/2
- •3. if complete primary cytoreduction is not feasible
- •4. in case of a known psychiatric disorder, substance abuse disorder, or high
- •suspicion of a mental disorder that could interfere with cooperation or
- •compliance with the requirements of the trial
- •5. when opting for fertility sparing surgery, or when breastfeeding
- •6. in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2
- •antibodies)
- •7. in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C
- •(e.g., HCV RNA
- •[qualitative])
- •8. patients who received prior treatment for the current malignancy.
研究者
相似试验
进行中（未招募）
1 期
A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patientsstage III epithelial ovarian cancerEUCTR2018-003346-17-NLKI-AV530
进行中（未招募）
1 期
A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patientsEUCTR2018-003346-17-SEKI-AV535
进行中（未招募）
1 期
A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patientsEUCTR2018-003346-17-DKKI-AV535
进行中（未招募）
1 期
aEpithelial Ovarian Cancer stage IIIMedDRA version: 20.0Level: LLTClassification code 10006888Term: Ca ovarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033163Term: Ovarian epithelial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003346-17-ITTHE NETHERLANDS CANCER INSTITUTE538
招募中
3 期
Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy:
OVHIPEC-22023-509049-11-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting500