A Phase III trial to assess the effectiveness of NRF2 activator (oral sodium-copper- chlorophyllin ) in locally advanced cervical cancer to reduce late radiotherapy toxicity.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 316
- 试验地点
- 2
- 主要终点
- Proportion of patients with cumulative late grade 2 or higher RT-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.
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.
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 90.00 Year(s)（—）
- 性别
- Female
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 with or without chemotherapy with brachytherapy.
- •Subjects who exceed the dose constraints of Rectum or sigmoid D2cm³ EQD2³ by greater than 70 Gy, or Bladder D2cm³ EQD2³ greater than 80 Gy. Subjects with adequate haematological renal hepatic and coagulation profiles and laboratory parameters within the following ranges Haemoglobin greater than or equal to 8 g per dl ANC greater than or equal to 1500mm3 Platelet count 100,000 mm3 Creatinine Clearance greater than or equal 50 ml min as per Cockcroft-Gault formula Bilirubin less than or equal to 2 multiplied by Upper limit of normal ULN AST and ALT less than or equal 1.5 multiplied by ULN.
- •Subjects willing and able to comply with all study requirements, including treatment example able to swallow tablets timing and or nature of required assessment.
- •Ability to understand and willing to sign an informed consent document.
排除标准
- •Subjects with known hypersensitivity or contraindication to study drug or to any known component of 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.
结局指标
主要结局
Proportion of patients with cumulative late grade 2 or higher RT-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.
时间窗: Patients will be assessed at 3-month intervals for 24 month. | for late grade 2 or higher RT-related gastrointestinal and genitourinary toxicities and any other changes.
次要结局
- Local Control, Pelvic Control Nodal Relapse Disease-Free Survival and Overall Survival (Patients not experiencing any event or patients who are alive up to the time of analysis will be censored on the date of the last follow-up)(At 24 month)
- To Assess Proportion of patients with any acute toxicity At treatment completion(For 4 weeks, 8 weeks and 12 weeks after treatment completion.)
- To Assess Proportion of patients with any haematological abnormalities (anaemia neutropenia thrombocytopenia)(At 3 months and 6 months after completion of RT)
- To Assess Proportion of patients with pre-diabetes diabetes mellitus and hypertension(At baseline and follow up)
- To Assess Proportion of patients with poor bone health as measured by DEXA scan vitamin B12 deficiency and vitamin D deficiency(At baseline and annually)
- To Assess Proportion of patients with RT-related urinary stress incontinence as measured by the Oxford scale at treatment completion(For 3 months 6 months and 9 months after completion of RT)
- Calculated cumulative time and severity incidence of toxicity scores(C-MOSES)(At the end of the study and during interim analysis)
- Patient-reported quality of life using EORTC-QLQ-C30 at baseline and all follow-ups(At 3, 6, 9, 12, 15, 18, 21 and 24 months after RT completion)
- Cost (in INR) of management of treatment-related toxicity in both arms(At the end of the study and during interim analysis)
- Levels and profiles of cytokines and NRF2 in all patients(At baseline, after CHL tablet completion,3 months after CHL tablet completion)
研究者
Dr Supriya Chopra
Tata Memorial Centre