Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.

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

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Capecitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Age ≥ 18 to 75 years at diagnosis

• Diagnosis of rectal adenocarcinoma

• ECOG status: 0～1

• Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)

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

• Leukocytes ≥ 4.0 x109/ L,

• Absolute neutrophil count (ANC) ≥ 2.0 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) ≤ 3 x ULN

• Aspartate aminotransferase (AST) ≤ 3 x ULN.

• Serum creatinine ≤ 1.5 x the ULN.

• Signed informed consent;

Exclusion Criteria:

• Patient had received pelvic radiotherapy

• Patient had received systemic chemotherapy

• Pregnant and Nursing women

• Had metastatic disease

• Uncontrolled co-morbid illnesses or other concurrent disease

• Patient had second malignant disease within 5 years

• Patients refused to signed informed consent.