Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Rate of clinical complete response
研究概览
简要总结
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
详细描述
Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.
A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.
The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.
The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal adenocarcinoma
- •cT3-4aNany or cTanyN+
- •Location ≤5 cm from the anal verge
- •No distant metastasis
- •No gastrointestinal obstruction or relieved obstruction
- •No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy
- •Expected survival length ≥ 2 years
- •Age 18-70
- •Sufficient bone marrow, kidney and liver function
- •Effective contraception during the study
- •Patient and doctor have signed informed consent
排除标准
- •Distant metastasis
- •Chronic intestinal inflammation and/or bowel obstruction
- •Contra indication for chemotherapy and/or radiotherapy
- •Previous pelvic radiotherapy or chemotherapy
- •Severe renal, hepatic insufficiency (serum creatinine<30ml/min)
- •Peripheral neuropathy > grade 1
- •Pregnant or breast-feeding woman
- •Certain or suspicious allergy to research drug
- •Cachexia, organ dysfunction
- •Active severe infection
- •Multiple primary cancers
- •Epileptic seizures
- •Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
- •Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
- •Uncontollable severe hypertesion
- •Persons deprived of liberty or under guardianship
- •Impossibility for compliance to follow-up
研究组 & 干预措施
TNT arm
Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.
External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.
干预措施: Capecitabine, Oxaliplatin (Drug)
TNT arm
Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.
External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.
干预措施: External beam radiotherapy (Radiation)
TNT arm
Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.
External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.
干预措施: Surgery (Procedure)
TNT arm
Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.
External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.
干预措施: Watch and wait strategy (Other)
结局指标
主要结局
Rate of clinical complete response
时间窗: 1.5 year after diagnosis
Rate of clinical complete response
次要结局
- Ratio of sphincter preservation strategy(1.5 year after diagnosis)
- Rate of pathological complete response and tumor regression grade distribution(1.5 year after diagnosis)
- Acute toxicity(Within the first course of anti-tumor treatment)
- Rate of surgical complications(1.5 year after diagnosis)
- Long-term anal function(1.5 year after diagnosis)
- Long-term toxicity grading(3 year after the end of the first course of anti-tumor treatment)
- ECOG standard score(1.5 year after diagnosis)
- 3 year disease free survival(3 year after the end of the first course of anti-tumor treatment)
- 5 year overall survival(5 year after the end of the first course of anti-tumor treatment)
研究者
WeiWei Xiao
Associate professor
Sun Yat-sen University