Overview

SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
Summary
Fluorouracil combined with oxaliplatin are routinely recommended to patients with pathological stage III (p-stage III) colorectal cancer, leading to significant improvement of 5-year disease-free survival and overall survival (approximately 3.4% -4.2%) by by international guidelines such as the National Cancer Comprehensive Network. The Considerable proportion of patients suffer with hand-foot syndrome due to capecitabine as commonly prescribed. Meanwhile as another agent of fluorouracil, tegafur,gimeracil and oteracil potassium (short for TGOP) has been shown with similar effect and less adverse reaction. This study was designed to investigate the short-term and long-term safety and efficacy of TGOP-OX and XELOX regimens in colorectal cancer p-stage III patients who undergo curative surgery and adjuvant chemotherapy, and to explore the compliance and quality of life in patients treated with TGOP-OX regime.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Cancer Hospital
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking Union Medical College Hospital
Peking University People's Hospital
Treatments:
Capecitabine
Oxaliplatin
Tegafur
Criteria
Inclusion Criteria:

- Signed written consent form;

- age ≥18 years old;

- randomization within 2-8 weeks after surgery;

- Performance status of the US Eastern Cancer Cooperative Group (ECOG) score 0-1;

- pathologically diagnosed as stage III colon or rectal adenocarcinoma patient;

- Accept effective contraceptive measures;

- postmenopausal women; pregnancy test negative 72 hours before randomization;

- R0 resection.

Exclusion Criteria:

- primary tumor metastasis (including tumor cells in the ascites or the occurrence of
peritoneal metastasis);

- presence of clinical relevant cardiovascular disease;

- presence of disease history of central nervous system, or evidence confirmed subjects
suffering from central nervous system diseases;

- presence of grade 3 (or over grade 3) peripheral neuropathy, according to the common
adverse event evaluation criteria (CTCAE) v. 3.0;

- post-operative radiotherapy must be implemented in patients according to researchers'
assessment,;

- presence of any unresolved toxicity left from previous anti-cancer treatment left >
grade 2 according to CTCAE, except hair loss;

- simultaneous use of targeted therapeutic drugs, such as anti-vascular endothelial
growth factor (VEGF) monoclonal antibody, or anti-epidermal growth factor receptor
(EGFR) monoclonal antibody;

- brain metastases or meningeal metastases;

- Insufficiency of bone marrow reserve capacity, the presence of neutrophils absolute
count ≤ 1.5 × 109 / L or platelet count ≤ 75 × 109 / L, or the need for regular blood
transfusion in order to maintain hemoglobin ≥ 9g / dL;

- Serum bilirubin ≥1.5 × upper limit of reference range (ULRR);

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × ULRR;

- serum creatinine ≥ 1.5 × ULRR or Cockcroft-Gault formula calculated creatinine
clearance ≤ 50ml / min;

- Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated
breathing, heart, liver or kidney disease, HIV infection, hypertension, severe
arrhythmia, diabetes, massive active bleeding);

- undergo a major surgery within 14 days prior to entering the study, or surgical
incision that has not yet healed completely;

- women who are pregnant or breastfeeding, or women who are positive for pregnancy
before the trial;

- subjects known to be allergic to oxaliplatin, capecitabine, S-1 or any ingredient of
these products;

- combination of other anti-cancer treatment (including gonadotropin-releasing hormone
agonists, anti-cancer Chinese medicine, immunotherapy), except for steroid hormones;

- In the past 5 years there are other malignant tumor history, except curative treatment
of skin basal cell carcinoma and / or cervical cancer in situ;

- have a significant history of gastrointestinal damage, the researchers judge may
significantly affect the absorption of S-1, including dysphagia;

- subjects known suffering dihydropyrimidine dehydrogenase (DPD) deficiency.