A Phase II/III Randomized Controlled Study of Neoadjuvant FOLFOX6 Treatment With or Without Radiation Compared to 5-Fu Based Chemoradiation in Treating Patients With Resectable Rectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- 3-year disease free survival
研究概览
简要总结
RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for local control after total mesentery excision being applied in routine practice is still unknown. And whether new drugs adding in can achieve better local and distant control is worth investigating.
PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX based radiation or FOLFOX alone, comparing them to see how well they work when given before surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more effective in treating rectal cancer.
详细描述
OBJECTIVES:
Primary Compare the objective response rate and the rate of local-regional relapse in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.
Secondary
- Compare the rate of pathologic complete response in patients treated with these regimens.
- Compare the local recurrence rate
2.Determine the increase in the number of patients who are able to undergo sphincter-saving surgery after treatment with these regimens.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adenocarcinoma of the rectum
- •Age: 18-75 years old
- •Stage of the primary tumor may be determined by ultrasound or MRI
- •Stage II (T_3-4, N_0 [N_0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T_1-4, N_1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]
- •Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
- •Distal border of the tumor must be located < 12 cm from the anal verge
- •Tumor amenable to curative resection
- •15 days prior recruit, meet the following criteria: Hematopoietic
- •Absolute neutrophil count ≥ 1,200/mm^3
- •Platelet count ≥ 100,000/mm^3 Hepatic
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN
- •AST ≤ 2 times ULN*
- •No hepatic disease that would preclude study treatment or follow-up
- •No uncontrolled coagulopathy Renal
- •Creatinine clearance > 50 mL/min
- •No renal disease that would preclude study treatment or follow-up
- •ECOG status: 0～1
排除标准
- •Hypersensitivity to fluorouracil, or oxaliplatin
- •No More than 4 weeks since prior participation in any investigational drug study
- •More than 4 weeks since prior participation in any investigational drug study
- •Clear indication of involvement of the pelvic side walls by imaging
- •With distant metastasis
- •History of invasive rectal malignancy, regardless of disease-free interval
- •Fertile patients must use effective contraception
- •Uncontrolled hypertension
- •Cardiovascular disease that would preclude study treatment or follow-up
- •Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
- •Synchronous colon cancer
- •Pregnant or nursing, Fertile patients do not use effective contraception
- •Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
- •No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
研究组 & 干预措施
A: 5Fu with Radiation
Patients receive fluorouracil IV continuously and undergo radiotherapy once daily 5 days a week for 5-6 weeks.
干预措施: fluorouracil (Drug)
B: FOLFOX with radiation
Patients receive FOLFOX for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFOX
干预措施: fluorouracil, oxaliplatin (Drug)
C: FOLFOX alone
Patients receive FOLFOX for 4 cycles
干预措施: fluorouracil, oxaliplatin (Drug)
结局指标
主要结局
3-year disease free survival
时间窗: 2 years
Compare 3-year disease free survival in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.
次要结局
- overall survival(5 years)
- R0 resection rate(1 year)
- quality of life(3 year)
- pathologic complete response rate(1 years)
- sphincter-saving surgery rate(1 year)
- predictive biomarkers(3 year)
- local recurrence rate(3 years)
研究者
Yanhong Deng
Doctor
Sun Yat-sen University