Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and XELOX chemotherapy in the patients with locally advanced rectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University, China
• Treatments: Capecitabine; Fluorouracil; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Age: 18-75 years old

• Primary and pathological diagnosis of rectal adenocarcinoma

• Radiographic evaluation of initial resectable rectal cancer

• T staging was determined by MRI as T3N+ or T4Nx

• Distal border of the tumor must be located < 12 cm from the anal verge

• ECOG status: 0～1

• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

Neutrophil count≥1.5×10^9/L Platelet count≥90×10^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 * ULN Alanine aminotransferase (ALT)≤2.5 * ULN Aspartate aminotransferase (AST)≤2.5 * ULN Alkaline phosphatase (ALP)≤2.5 * ULN

• Signed informed consent; able to comply with study and/or follow- up procedures

Exclusion Criteria:

• Previous treatment with oxaliplatin, irinotecan or fluorouracil

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.

• Clear indication of involvement of the pelvic side walls by imaging

• With distant metastasis

• A history of malignant rectal cancer (i. e. sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer

• Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months

• Digestive system diseases that would preclude study treatment or follow-up within the past 6 months

• Gastric ulcers or duodenal ulcers for the treatment of resistance;

• 3 or 4 grade gastrointestinal bleeding / bleeding;

• Gastrointestinal perforation / fistula;

• Abdominal abscess;

• Infectious or inflammatory bowel disease

• HIV infection and/or active hepatitis B virus infection

• Pregnant or lactating women. Fertile patients must use effective contraception

• Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study

• Other intervention clinical trials were combined at the same time.

• Nerve or mental abnormality affecting cognitive ability

• Other malignancy except effectively treated squamous cell or basal cell skin cancer,

• Other situations that the researchers think should be excluded