CTRI/2019/11/021924招募中3 期
ââ?¬Å?A phase III randomised trial of metronomic maintenance with oral methotrexate and propranolol versus observation after chemotherapy in relapsed platinum sensitive high grade epithelial ovarian cancerââ?¬?.
Applied for Extramural grant0 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
- •Inclusion Criteria
- •i.Patients with high grade epithelial ovarian cancer who relapse 6 months after primary treatment with platinum based chemotherapy and achieve complete or partial response or stable disease after re challenge with platinum based doublet .
- •ii.Performance Status - ECOG 0-2.
- •iii.Screening Laboratory Values within the following limits
- •a)Absolute Neutrophil count (ANC) ââ?°Â¥1500/mm 3
- •b)Platelet Count ââ?°Â¥ 100,000/mm3
- •c)Haemoglobin ââ?°Â¥ 9gm/dl
- •d)S Creatinine ââ?°Â¤1.5 upper limit of normal (ULN)
- •e)S Bilirubin ââ?°Â¤ 1.5 (ULN)
- •f)Aspartate Aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2 times ULN.
- •iv.Patients who have signed and dated informed consent document.
- •v.Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Exclusion Criteria
- •i.Epithelial ovarian cancer with Mucinous or Clear cell histology
- •ii.Pre -existing use of selective or non- selective Ã?² blockers
- •iii.Patients with Bronchial asthma or COPD or interstitial lung disease
- •iv.Patients with congestive heart failure, sinus bradycardia (HR <60) or any degree heart block, or any arrythmia
- •v.Patients with left ventricular ejection fraction less than 50%
- •vi.Hypersensitivity to propranolol or methotrexate
- •vii.LFT ââ?°Â¥ twice upper limit of normal
- •viii.Those with reactive HIV, HBsAg, Anti HCV status
- •ix.Patients with active tuberculosis
- •x.Patients on concomitant medications with significant interaction with propranolol and methotrexate where the concomitant medication cannot be substituted.
- •xi.Those who could be planned for potential secondary cytoreduction.
- •xii.Patients willing and affording for PARP inhibitor as maintenance.
研究者
相似试验
进行中（未招募）
1 期
A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 9.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)MedDRA version: 9.1Level: LLTClassification code 10025632Term: Malignant lymphomaEUCTR2007-000821-23-BEniversity Medicine Goettingen274
进行中（未招募）
1 期
A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 9.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)MedDRA version: 9.1Level: LLTClassification code 10025632Term: Malignant lymphomaEUCTR2007-000821-23-ATniversity Medicine Goettingen276
进行中（未招募）
1 期
A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 years ICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 9.1 Level: LLT Classification code 10002464 Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)MedDRA version: 9.1 Level: LLT Classification code 10025632 Term: Malignant lymphomaEUCTR2007-000821-23-FRniversity Medicine Goettingen274
进行中（未招募）
1 期
A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)MedDRA version: 9.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 9.1Level: LLTClassification code 10025632Term: Malignant lymphomaEUCTR2007-000821-23-SEFaculty of Medicine at Georg August University,Goettingen, Germany274
进行中（未招募）
1 期
A-CHOP-14 (elderly)Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/39717/39716/39708/39705/39714/3MedDRA version: 18.1Level: LLTClassification code 10025632Term: Malignant lymphomaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)System Organ Class: 100000004864EUCTR2007-000821-23-NLniversity Medicine Goettingen116