ISRCTN61007118进行中（未招募）Unknown
THERApy de-escalation for TESTicular cancer
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Male
入选标准
- •Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- •1. Willing and able to provide written informed consent
- •3. Age = 16 years
- •4. Histologically confirmed seminoma (biopsy/orchidectomy)
- •5. Clinical stage II (standard of care cross-sectional imaging)
- •6. Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcome questionnaires. rRPLND cohort-specific inclusion criteria
- •Participants must meet the following additional inclusion criteria to register for the rRPLND cohort:
- •1. Stage IIA and <3cm IIB with unifocal ipsilateral lymph node within rRPLND template.
- •2. Negative or mildly elevated serum tumour markers, defined as:
- •2.1. AFP (alpha-fetoprotein) <10ng/ml and non-rising on serial testing
- •2.2. BhCG (human chorionic gonadotropin) <50mg/ml
- •2.3. LDH (lactate dehydrogenase) <1.5x upper limit normal
- •3. Fit for surgery, defined as meeting all of the following criteria:
- •3.1. Body mass index (BMI) <34
- •3.2. Charlson comorbidity index =3
- •3.3. ECOG Performance status 0-1
- •3.4. No significant cardio-pulmonary disease, or other uncontrolled intercurrent illness that would limit fitness for surgery in the opinion of the investigator
- •3.5. No previous open intra-abdominal surgery Carboplatin AUC10 cohort-specific inclusion criteria
- •Participants must meet the following additional inclusion criteria to register for the Carboplatin AUC10 group:
- •1. Serum tumour markers, defined by IGCCCG good risk” criteria:
- •1.1. AFP <10ng/ml
- •1.2. any BhCG
- •1.3. LDH <2.5x ULN
- •2. Glomerular filtration rate by EDTA clearance over 25 ml/min (a measured creatinine clearance using Cockcroft and Gault would be allowed if unable to perform EDTA clearance)
- •3. ECOG Performance status 0-2
- •4. Patients must be sterile or agree to use adequate contraception during the period of therapy
排除标准
- •A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Raised AFP > 10ng/ml that does not fall to <10ng/ml following orchidectomy
- •2. Previous chemotherapy or radiotherapy for the disease under study.
- •3. Previous or concurrent malignancy other than testicular cancer, unless treated with curative intent and with no known active disease present for =2 years before enrolment and felt to be at low risk for recurrence by the treating physician (for example: non-melanoma skin cancer or lentigo maligna; breast ductal carcinoma in situ; prostatic intraepithelial
- •neoplasia; urothelial papillary non-invasive carcinoma or urothelial carcinoma in situ).
- •4. Any condition that, in the opinion of the investigator, would interfere with the evaluation of study intervention or interpretation of patient safety or study results such as medical comorbidities impacting on QoL or medical conditions or other disorders that would affect adherence to study requirements.
研究者
相似试验
进行中（未招募）
不适用
Treatment of Patients Suffering from Tumour Cachexia with Dronabinol (tetrahydrocannabinol) or PlaceboComparison of individually optimised dosages in a double blind, randomised parallel design - Dronabinol for tumour cachexiaEUCTR2007-002968-10-ATDepartment of Medicine I, Clinical Dep. f. Oncology, University Hospital,74
尚未招募
不适用
Study on the combined scheme of Quxie Capsule in the third-line treatment of metastatic colorectal cancer and the characteristics of the dominant populatiocolorectal cancerITMCTR2200006487XiyuanHospital of CACMS
招募中
不适用
Follow-up after treatment for testicular cancer: the prospective, single centre FUTURE-testis implementation study10038588testicular tumorTesticular cancerNL-OMON51942Erasmus MC, Universitair Medisch Centrum Rotterdam145
已完成
不适用
Transmurale zorg Prostaatkanker, van diagnose tot en met nazorgProstate cancer, transmural care, decision aid, SDM, Follow-up care, Substitution, Family doctors or General practitioners, Prostaatkanker, Keuzehulp, Samenwerking tussen eerste lijn en tweede lijn.NL-OMON22953Initiator: Catharina Wilhelmina Hospital (CWZ)NijmegenPrimary Sponsor/Performer: Radboud University Nijmegen Medical centerOther performers: CWZ in Nijmegen, Maashospital Pantein in Boxmeer200
进行中（未招募）
1 期
Response evaluation with 68Ga-PSMA PET of metastatic prostate cancer castration resistant patients in treatment with 223RaCl2Patients mCRPC eligible to treatment with 223RaCl2MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001395-38-ITAZIENDA USL DELLA VALLE D'AOSTA50