Phase II Randomized Study of Short Course Radiotherapy Based Total Neoadjuvant Therapy & Brachytherapy Boost With Or Without Chlorophyllin In Watch And Wait Suitable Locally Advanced Rectal Cancer (SCOTCH Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Acute Toxicity
研究概览
简要总结
The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer.
This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment.
Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.
详细描述
The current standard treatment for locally advanced rectal cancer includes neoadjuvant (treatment given before Surgery) radiotherapy & chemotherapy followed by surgery if needed or wait and watch in patients whom tumour has completely regressed. It has been observed that even after receiving this intensive treatment patients, almost 70% of patients develop acute toxicity (during or within 3 months) of grade 2 or higher (needing medication for toxicity). This affects their treatment tolerance, completion and quality of life.
In this study Researchers are going to see if addition of drug Chlorophyllin (derived from green plant leaves) along with standard treatment would help in reducing the acute toxicity. Chlorophyllin is present in all green leaves of plants giving them green color. The drug is derived from green plant leaves. As it is a plant-based product it is safe for humans and has no known side effects of its own. This is a randomized study which has two arms; Arm 1 is test arm where participants will receive drug of interest (Chlorophyllin) and in other arm participants will receive Placebo. Upon successful completion of study, outcomes from both the study arm will be compared and participants will be followed by standard protocol for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- •Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
- •Non-circumferential tumours with craniocaudal length <7 cm
- •The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
- •No evidence of distant metastases on CT Chest and Abdomen.
- •No prior pelvic radiation therapy
- •No prior chemotherapy or surgery for rectal cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
- •Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
- •Absolute neutrophil count (ANC) > 1.5 cells/mm3, hemoglobin (HGB) > 8.0 gm/dl, platelet (PLT) > 150,000/mm
- •Total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), aspartate aminotransferase (AST) ≤ 3 x ULN, alanine transaminase (ALT) ≤ 3 x ULN.
排除标准
- •Signet or mucinous histology cancer of rectum
- •Recurrent rectal cancer or previous pelvic radiotherapy
- •Primary unresectable rectal cancer.
- •Creatinine level greater than 1.5 times the upper limit of normal.
- •Patients who are unable to undergo an MRI.
- •Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- •Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- •Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
- •Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
- •Poor reliability for follow up.
- •Ineligible as per eligibility criteria
研究组 & 干预措施
Chlorophyllin
Drug name: Sodium Copper Chlorophyllin Dosage form: Tablet Dosage: 750 mg Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy
干预措施: Chlorophyllin, Sodium Copper Complex (Drug)
Placebo
Drug Name: Placebo Dosage form: 1 Tablet Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Toxicity
时间窗: 3 months post-last cytotoxic therapy.
Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT) in advanced rectal cancer. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 late toxicity means a good outcome. Grade 2 or higher late toxicity means a worse outcome.
次要结局
- Overall successful complete response rates(3 years)
- Organ preservation rates(3 years)
- Disease free survival(3 years)
- Treatment related early and late toxicities(2 years)
- Estimation of surgical complications(30 days post surgery)
- Health related quality of life(2 years)
- Cost benefit with reduction in toxicity(2 years)
- Tumor Volume reduction kinetics(2 years)
- To evaluate the timeline of Occurence(3 years)