A Phase III Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity. (CHOC-LATE Trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 316
- 主要终点
- Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence
研究概览
简要总结
Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages.
The standard treatment for these stages is concurrent chemoradiotherapy, but this can cause long-term side effects such as bladder inflammation, strictures, ulcers, and tissue damage, which negatively impact patients' quality of life.
Previous studies have shown that oral sodium-copper-chlorophyllin can help reduce radiation-related side effects in rectal, prostate, and cervical cancer patients. However, no study has compared side effects between patients receiving standard follow-up care and those taking sodium-copper-chlorophyllin during follow-up.
We hypothesize that the use of sodium-copper-chlorophyllin as a short-duration adjuvant is associated with reduced incidence of late grade 2 or higher gastrointestinal and genitourinary toxicities compared to patients receiving standard-of-care follow-up.
详细描述
Descriptive summary
Objectives
Primary objective
• To assess the effectiveness of adjuvant sodium-copper-chlorophyllin in reducing the cumulative incidence of late grade 2 or higher RT-related gastrointestinal and genitourinary toxicity in cervix cancer patients, measured using the time-to-event method
Secondary objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix
- •Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.
- •Subjects who exceed the dose constraints of:
- •Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
- •Bladder D 2cm³ EQD2 ³ more than 80 Gy
- •Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:
- •Haemoglobin: ≥ 8 g/dl
- •ANC ≥ 1,500/mm^3
- •Platelet count 100,000/mm^3
- •Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)
- •Bilirubin: ≤ 2 x Upper limit of normal (ULN)
- •AST and ALT: ≤ 1.5 x ULN
- •Subjects willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
- •Ability to understand and willingness to sign an informed consent document
排除标准
- •Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation
- •Subjects with clinically significant decreased hematologic reserves, with major organ failure, severe electrolyte or metabolic abnormalities, any active infection or any other medical condition that may interfere with the ability to receive study treatment
- •HIV positive patients
- •Subjects with a history of blood dyscrasias
- •Subjects consuming any other concurrent investigational agents
- •Subjects with any other previous or current malignancy or RT that is likely to interfere with the protocol treatment, or any other condition which, according to the principal investigator, might make an individual unsuitable for this study
- •Subjects participating in any other clinical study within 90 days before enrolment in the study
- •Subjects on active anti-coagulant treatment
研究组 & 干预措施
Arm 1: Test arm
Oral adjuvant sodium-copper-chlorophyllin 750mg given once daily, given on an empty stomach for 3 months, starting within 2 weeks of radiotherapy completion
干预措施: Sodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts. (Dietary Supplement)
Arm 2: Standard
Standard-of-care follow-up post radiotherapy
结局指标
主要结局
Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence
时间窗: 24 months
Proportion of patients with cumulative late grade 2 or higher radiotherapy-related gastrointestinal and genitourinary toxicity incidence, reported using the time-to-event method, taken from the date of random assignment to the occurrence of late toxicity, or death because of late toxicity, at 24 months after completion of RT, by addition of sodium-copper-chlorophyllin for 3 months post RT (starting within 2 weeks of treatment completion), as compared to standard-of-care follow-up.
次要结局
- Local Control at 24 months(24 months)
- Pelvic Control at 24 months(24 months)
- Proportion of patients with radiotherapy-related urinary stress incontinence(At treatment completion, 3 months, 6 months, 9 months)
- Nodal Relapse at 24 months(24 months)
- Cumulative C-MOSES score(24 months)
- Disease-Free Survival at 24 months(24 months)
- Overall Survival at 24 months(24 months)
- Proportion of patients with any acute toxicity(4 weeks, 8 weeks and 12 weeks post radiotherapy completion)
- Proportion of patients with any haematological abnormalities(3 months and 6 months post radiotherapy completion)
- Patient-reported quality of life (QoL)(3, 6, 9, 12, 15, 18, 21 and 24 months after radiotherapy completion)
- Cost of management of radiotherapy-related toxicity(24 months)
研究者
Supriya Sastri (chopra)
Dr. Supriya Chopra
Tata Memorial Hospital