NCT03013946终止3 期
A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 121
- 试验地点
- 43
- 主要终点
- QoL assessment during sunitinib treatment: questionnaire
研究概览
简要总结
The primary objective of the trial is to determine the effect of a 24-week concomitant coaching on patient reported outcomes of patients receiving standard treatment for mRCC with sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.
详细描述
The goal of our study is to define the benefit of proactive coaching in mRCC, when compared to a reactive approach, which is considered the standard of care.
Patients in the Coaching Arm A will be trained continuously at personal interactions of coach and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.
Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •Age ≥ 18 years at time of study entry
- •Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
- •Intended first-line treatment with sunitinib
- •Documented progressive disease within 6 months prior to study inclusion
- •Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
- •Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
- •Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- •Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.
排除标准
- •Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
- •Previous malignancy (other than mRCC) which either progresses or requires active treatment.
- •Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].
- •CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
- •Chronic liver disease with Child-Pugh B or C score
- •Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
- •Participation in another clinical study with an investigational product during the last 30 days before inclusion
- •Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
- •Previous enrollment or randomization in the present study (does not include screening failure).
- •Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
- •Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
- •Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
- •Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
结局指标
主要结局
QoL assessment during sunitinib treatment: questionnaire
时间窗: 24 weeks from randomization
Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.
次要结局
- Time to first subsequent therapy (TFST)(up to 36 months)
- progression-free survival (PFS)(up to 36 months from randomization)
- Patient adherence / treatment discontinuation due to Adverse drug reactions (ADRs) / Serious adverse events (SAEs):(24 weeks from randomization)
- Assessment of comorbidities(at inclusion)
- Overall Survival (OS)(up to 36 months from randomization)
- Treatment Emergent Adverse Events according to CTC 4.03:(24 weeks from randomization)
- Objective Response Rate (ORR) according to RECIST 1.1 criteria(up to one year from randomization)
- Duration of treatment (coaching and cancer treatment)(Coaching: up to 24 weeks from randomization / cancer treatment: up to 36 months from randomization)
- Rate of patients receiving treatment beyond progression(up to 36 months from randomization)
- dose density of sunitinib(24 weeks from randomization)
- Further cancer treatment(up to 36 months)
研究者
研究点 (43)
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