Risk stratified SPA score versus Physician decision chemotherapy dosage in patients with palliative chemotherapy to reduce treatment Toxicity- Open label, Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Incidence of Grade more than or equal to 2 non-haematological and Grade more than or equal to 3 haematological chemotherapy-related toxicity by NCI CTCAE v5.0
研究概览
简要总结
This is a single-centre academic study to be conducted at JIPMER. Enrollment will start in July
Project title: Risk stratified SPA score versus Physician decision chemotherapy dosage in patients with palliative chemotherapy to reduce treatment toxicity- Open label, Randomised controlled Trial (SPART)
Aim:
To compare the SPA score categorised tailoring of chemotherapy dose versus physicians’ decision, both combined with olanzapine, to reduce treatment toxicity and improve survival
Research question: Does SPA score-categorised dose tailoring of chemotherapy versus physicians’ decision, both combined with olanzapine, reduce the incidence of grade 2 or higher toxicity during 12 weeks of chemotherapy in patients receiving palliative chemotherapy in Lung, Gastroesophageal and Pancreaticobiliary malignancy?
Primary objective: To compare the incidence of grade more than or equal to 2 non-haematological and grade grade more than or equal to 3 haematological chemotherapy-related toxicity during 12 weeks of chemotherapy based on NCI CTCAE v5.0 among patients receiving SPA score-categorised tailoring of chemotherapy dose versus physicians’ decision, combined with olanzapine in patients receiving palliative chemotherapy in Lung, Gastroesophageal and Pancreaticobiliary malignancy.
Secondary objectives: To compare the 2 groups for
-
Cumulative frequency of haematological Grade more than or equal to 3 and non-haematological Grade more than or equal to 2 chemotherapy-related toxicity during the 12 weeks of chemotherapy
-
Response rates by RECIST 1.1 criteria
-
Dose intensity, delays and modifications
-
Chemotherapy discontinuation rates
-
Progression-free survival at 1 year
-
Overall survival at 1 year
-
Quality of life measured by the Cancer Institute-Quality of Life Questionnaire
Methodology:
Patients planned for palliative chemotherapy will be screened. Patients fulfilling the inclusion and exclusion criteria are included in the study. Patients will be randomised into two arms
Arm A (Intervention): Chemotherapy dose adjustments based on the SPA risk score + Olanzapine
Arm B (Control Group): Physician’s choice of chemotherapy dose + Olanzapine
The highest score will be determined by selecting the value among the three variables
•Low Risk: All parameters within the low-risk column (100% dose of chemotherapy)
•Intermediate Risk: Any one or more parameter not fulfilling the low-risk columns would be considered intermediate risk (80% dose of chemotherapy)
•High Risk: Any one parameter within the high-risk column (60% dose of chemotherapy)
Arm B will receive the physician’s decision of the chemotherapy dose along with the tablet Olanzapine 2.5 mg once daily up to 12 weeks
Baseline SGA score, PS, serum albumin, and CI-QoL II questionnaire will be recorded. Before each chemotherapy cycle and at 12 weeks, toxicity grading by CTCAE version 5.0 and CI-QoL II questionnaire will be done
sample size: 206 patients, 103 in each arm
Intention to treat: All patients who are randomised and initiated on treatment with chemotherapy with olanzapine, based on groups, will be analysed. If not started on treatment will be replaced.
In patients for whom toxicity assessment is not available at 12 weeks, they will be analysed in two ways
-
They will be considered to have a negative outcome
-
They will be counted as an event
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed cancer (lung, gastroesophageal, pancreaticobiliary (PB)) cancers
- •Locally advanced inoperable and metastatic cancer patients not suitable for curative therapy and planned for first-line palliative chemotherapy
- •Patients who have previously received adjuvant/neoadjuvant chemotherapy can be included in the study if they have received chemotherapy more than 6 months before randomization
- •No major surgery within the last 4 weeks, excepting palliative surgeries like colostomy, GJ, biliary drainage, etc.
- •Haematological, hepatic, and renal function parameters satisfying the parameters mentioned below.
- •a. Haematological- Hb more than 80 g/L, ANC more than or equal to 1.5 x 10 raised to 9/L, platelets more than or equal to 100 x 10 raised to 9/L. b. Liver function- bilirubin less than or equal to 2 x upper limit normal (ULN), AST/ALT less than or equal to 5 times ULN c. Renal function- Creatinine clearance more than or equal to 40 mL/min d. Baseline ECG/2D Echocardiography LVEF more than or equal to 50%.
排除标准
- •Known hypersensitivity or contraindication to chemotherapy drugs used in the study
- •Do not give consent for the study
- •Pregnancy or lactation
- •Patient planned for targeted therapy alone
- •Symptomatic, untreated brain metastasis.
结局指标
主要结局
Incidence of Grade more than or equal to 2 non-haematological and Grade more than or equal to 3 haematological chemotherapy-related toxicity by NCI CTCAE v5.0
时间窗: Assessed before each cycle and at 12 weeks
次要结局
- Change in quality of life by Cancer Institute-Quality of Life Questionnaire(Assessed before each cycle and at 12 weeks)
- Cumulative frequency of haematological Grade more than or equal to 3 and non-haematological Grade more than or equal to 2 chemotherapy-related toxicity(Assessed before each cycle and at 12 weeks)
- Disease response rates by RECIST 1.1 criteria(12 weeks)
- Dose intensity, delays and modifications(Assessed before each cycle and at 12 weeks)
- Chemotherapy discontinuation rates(12 weeks)
- Progression-free survival(1 year)
- Overall survival(1 year)
研究者
Biswajit Dubashi
Jawaharlal Institute of Postgraduate Medical Education and Research