JPRN-jRCT1031220676招募中3 期
JCOG2011: A randomized controlled phase III trial for confirming superiority of local radiotherapy added to anti-androgen therapy for prostate cancer patients with high volume metastasis sensitive to hormone therapy - HimeRT study
KAMOTO Toshiyuki0 个研究点目标入组 440 人开始时间: 2023年3月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
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
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1) Histologically diagnosed as acinar adenocarcinoma by prostate needle biopsy
- •2) One of the following <1><2> in the imaging test before the primary registration.
- •<1> Bone metastasis is confirmed by bone scintigraphy and meets all of the following i) and ii).
- •i) The number of bone metastases is 4 or more.
- •ii) 1 or more bone metastatic lesion outside the pelvis and vertebral bodies.
- •<2> Visceral metastasis (other than bone, lymph nodes, and skin) is observed on contrast-enhanced CT.
- •3) Males aged 18 years or older.
- •4) ECOG Performance status 0 to 2.
- •5) No ADT or within 84 days (12 weeks) from ADT start. If ADT has been started before the primary registration, one of the following <1> or <2>.
- •<1>All of the following i) and ii) when ADT with drugs is performed.
- •i) Goserelin, leuprorelin, or degarelix is not discontinued at primary enrollment.
- •ii) Within 84 days (12 weeks) from the day of the first administration of ADT.
- •<2> Within 84 days (12 weeks) from the day of the bilateral orchiectomy as ADT.
- •6) ARAT (abiraterone + prednisolone, enzalutamide, apalutamide) has not been administered.
- •7) presence or absence of measurable lesions does not matter.
- •8) No history of administration of docetaxel for prostate cancer.
- •9) No history of local surgical treatment or radiotherapy for prostate cancer. However, if there is a history of radiation to bone metastases in the pelvic region or testicular tumor, consult with a radiologist/radiation oncologist to ensure that the total radiation dose is less than a limited dose for each organ.
- •10) Adequate function of major organs.
- •11) Written informed consent.
- •1) After the primary registration protocol treatment was not discontinued by the date of the secondary registration.
- •2) The cumulative days of ARAT administration (total number of administration days) after primary registration is 84 days or more.
- •3) All of the following <1> and <2>.
- •<1> No exacerbation of the primary disease was observed in any of the evaluations.
- •<2> Neither suspected progression of bone lesions nor suspected progression of PSA.
- •4) From 168 days (24 weeks) to 196 days (28 weeks) from the primary registration date.
- •5) The date of secondary registration is 28 days (4 weeks) from the date of second imaging evaluation.
- •6) Performance status is 0 to 2.
- •7) Adequate function of major organs.
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies.
- •2) Infectious disease requiring systemic treatment.
- •3) Pyrexia of 38 or higher degrees centigrade.
- •4) Poorly controlled hypertension.
- •5) Male expecting partner's pregnancy.
- •6) Severe psychological disorders.
- •7) Patients receiving systemic steroids or other immunosuppressive drugs.
- •8) Positive HIV antigen.
研究者
相似试验
招募中
3 期
JCOG1801: A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancerresectable locally recurrent rectal cancerJPRN-jRCTs031190076Ito Masaaki110
招募中
3 期
JCOG1905: A randomized controlled phase III trial on continued or paused PD-1 pathway blockade for patients with advanced renal cell carcinomaadvanced renal cell carcinomaJPRN-jRCT1031200071MATSUMOTO Takashi250
进行中（未招募）
3 期
JCOG1109: A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancerclinical stage IB/II/III thoracic esophageal cancerJPRN-jRCTs031180202Kato Ken600
招募中
3 期
JCOG1904: A randomized controlled phase III trial of comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal canceresophageal cancerJPRN-jRCTs031200067TSUSHIMA Takahiro176
招募中
3 期
JCOG2207: A phase III randomized controlled trial comparing total mesorectal excision and lateral lymph node dissection plus adjuvant chemotherapy with total neoadjuvant therapy followed by total mesorectal excision and selective lateral lymph node dissection for the patients with locoregionally advanced low rectal cancerRectal cancerJPRN-jRCTs031230415OHUE Masayuki420