Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

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

Details

• Lead Sponsor: Kyungpook National University Hospital
• Collaborator: National Cancer Center(NCC)

Criteria

Inclusion Criteria:

• Asian

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2

• Histologically proven rectal cancer (the lowest border of the tumor located ≤ 10 cm from the anal verge)

• Histological type: adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma

• at least one of the following criteria on pelvic MRI (cTanyN1-2, cT3-4N0, TanymrEMVI (+))

• MRI scan findings such as pelvic lymph node metastases, sphincter i involvement, (mesorectal fascia) (MRF) (+), and T4b are not exclusion criteria, and are at the discretion of the researcher.

• Adequate hematologic/renal/hepatic function WBC > 3.0×109/L, Platelet>100×109/L / direct bilirubin<0.4mg/dl / GFR>50ml/min by Wright or Cockroft formula /

• Patients who listen to and understand the explanation of the study and sign the consent form

Exclusion Criteria: (one of the following criteria)

• Colon cancer or rectal cancer located at above the anal verge 10 cm

• cT1-2N0 on pelvis MRI (magnetic Resonance Imaging)

• Distant metastasis

• Familial Adenomatous polyposis

• Hereditary non-polyposis colorectal cancer

• Systemic chemotherapy or radiotherapy within 6 months

• History of colorectal cancer

• or other type of malignancy within 5 years (Exceptions are made for cured non-melanoma skin cancer or in situ neck cancer.)

• Patients who are is judged that it is difficult to receive chemotherapy or radiotherapy due to an underlying disease or systemic condition

• Patients with bone marrow suppression with neutrophil count < 2 x 109/L and/or platelet count < 100 x 109/L prior to the first chemotherapy administration cycle

• Patients with peripheral sensory neuropathy with functional impairment prior to the first administration cycle (grade 2 or higher) (peripheral nerve symptoms may worsen)

• Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula)

• Severe hepatic dysfunction

• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

• Patients receiving Tegafur, Gimeracil, and Oteracil potassium combination drugs and those within 7 days of discontinuation

• Patients receiving sorivudine or brivudine

• Patients with a history of another malignant disease within the last 5 years

• Patients with clinically significant heart disease or myocardial infarction within the past 6 months

• A history of hereditary diseases or hemocoagulopathy that pose a risk of bleeding

• Patients with central nervous system disorders or a history of mental disorders and patients with evidence of central nervous system metastases

• Pregnant or lactating women

• Patients currently participating in other clinical trials or receiving investigational drugs

• Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity

• Active gastrointestinal bleeding

• Active infections requiring antibiotics for injection

• Emergency Surgery

• Patients with a history of hypersensitivity reactions to the components of the investigational drug

• Patients with non-malignant tumor diseases

• Patients known to have dihydropyrimidine dehydrogenase deficiency

• Patients who do not wish to participate in this study