Status:
UNKNOWN
Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
China Medical University, China
Conditions:
Rectal Neoplasms
Drug Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 pa...
Detailed Description
Neoadjuvant chemoradiation therapy with double cytotoxic agents is the standard treatment for the patients with locally advanced rectal cancer. Conventional treatment reduced the local recurrence but ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03484221
Start Date
April 1 2018
End Date
April 1 2022
Last Update
April 14 2021
Active Locations (1)
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1
China Medical University
Shenyang, China