FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study

• Status: Recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR. Total neoadjuvant treatment had been evaluated a lot in recent years, including induction chemotherapy or consolidation chemotherapy, or concurrent chemoradiotherapy. We aimed to evaluated the safety and efficacy of total neoadjuvant treatemnt in locally advanced rectal cancer.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Diagnosis of adenocarcinoma of the rectum

• Age: 18-70 years old

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

• Stage of the primary tumor may be determined by ultrasound or MRI

• Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T1-4, N1-2 [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

• 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.

• Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.

• No renal disease that would preclude study treatment or follow-up

• ECOG status: 0～1

Exclusion Criteria:

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.

• 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

• patients refused to signed informed consent.