Short course radiotherapy based total neoadjuvent therapy with or without chlorophyllin
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Incidence of grade 2 or higher acute GI/GU/haematological toxicity
研究概览
简要总结
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 we are going to see if addition of drug Chlorophyllin along with standard treatment, would help 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 will receive drug of interest (Chlorophyllin) and in other arm you will receive Placebo. Upon successful completion of study, outcomes from both the study arm will compared and you will be followed by standard protocol for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age > 18 years.
- •2.Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- •3.Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
- •4.Non-circumferential tumours with craniocaudal length <7 cm 5.The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
- •6.No evidence of distant metastases on CT Chest and Abdomen.
- •7.No prior pelvic radiation therapy 8.No prior chemotherapy or surgery for rectal cancer 9.ECOG Performance status 0-2 10.Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
- •11.Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
- •ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, 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), AST≤ 3 x ULN, 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 investigators judgment would make them inappropriate candidates for entry into this study.
- •Poor reliability for follow up.
- •Ineligible as per eligibility criteria.
结局指标
主要结局
Incidence of grade 2 or higher acute GI/GU/haematological toxicity
时间窗: 3 months post-last cytotoxic therapy.
次要结局
- To estimate the 2-year organ preservation rates, TME free survival and if any difference between chlorophyllin and control arms.(2 years)
- To estimate the 2-year disease free survival, Distant metastasis free survival, loco-regional failure free survival, and overall survival rates in the whole cohort, and if any difference between two arms and between patients with successful NOM versus others.(2 years)
- To estimate the 2-year overall complete response rates (clinical or pathological) in whole cohort and if any difference between chlorophyllin and control arms.(2 years)
- To compare treatment-related early and late toxicities (grade 2 CTCAE v5) for two years between the groups as (3).(2 years)
- To estimate surgical complications based on Clavien-Dindo classification(30 days post surgery)
- To estimate and compare Health Related Quality Of Life (EORTC QOL-C30, CR 29, PRT 20, SH 22), and LARS, IPSS scores between various groups as (3).(2 years)
- To estimate direct cost benefit with reduction in toxicity(2 years)
- To study the tumour volume reduction kinetics and radiotherapy doses and probability of successful NOM outcomes.(2 years)