FOLFOXIRI Chemotherapy Alone as Neoadjuvant Treatment for Circumferential Radial Margin (CRM) Positive Rectal Cancer

• Status: Withdrawn
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally advanced rectal cancer. However, radiation-related side effects could not be neglected. But this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be an alternative strategy to minimize treatment-related toxicities without compromising the oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6 cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients with locally advanced rectal cancer.

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

Details

• Lead Sponsor: Guangxi Medical University
• Treatments: Fluorouracil; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Diagnosis of adenocarcinoma of the rectum

• Age: 18-70years old

• Signed informed consent; able to comply with study and/or followup procedures

• Stage of the primary tumor may be determined by MRI as CRM positive

• Tumor amenable to curative resection

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

• Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.

• Total bilirubin ≤1.5 x the upper limit of normal (ULN).

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.

• Alkaline phosphatase limit ≤ 5x ULN.

• Amylase and lipase ≤ 1.5 x the ULN.

• Serum creatinine ≤ 1.5 x the ULN.

• No renal disease that would preclude study treatment or followup

• ECOG status: 0～1

Exclusion Criteria:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.

• Less than 4 weeks since prior participation in any investigational drug study

• History of invasive rectal malignancy, regardless of disease free interval

• Uncontrolled hypertension

• Cardiovascular disease that would preclude study treatment or followup

• Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding

• Synchronous colon cancer

• Pregnant or nursing

• 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

• patients refused to signed informed consent.