Adjuvant Chemotherapy Clinical Trial
Official title:
A Prospective Randomized Controlled Trial to Compare Oxaliplatin Combined With S-1 (SOX) Versus Oxaliplatin With Capecitabine (XELOX) as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
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.
In patients with pathological stage III colorectal cancer, capecitabine combined with
oxaliplatin, as routinely prescribed for adjuvant chemotherapy prolongs the patient's 5-year
disease-free survival and overall survival (about 3.4% -4.2%) and is therefore recommended by
the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology
(ESMO) and other international guidelines. Accumulating evidence has shown that a majority of
chemotherapy-related side effects were caused by capecitabine, especially in certain patients
with hand-foot syndrome lasting a long time. Tegafur,gimeracil and oteracil potassium (TGOP),
as another fluorouracil, was shown to be equally effective for colorectal cancer patients as
adjuvant chemotherapy. The results of two multicenter randomized controlled trials (Adjuvant
Chemotherapy Trial of S-1 for Colon Cancer and Adjuvant Chemotherapy Trial of S-1 for
RectalCancer) reported at the American Society of Clinical Oncology (ASCO) 2015 suggested
that patients with stage III colorectal cancer treated with tegafur,gimeracil and oteracil
potassium (TGOP) instead of capecitabine for adjuvant chemotherapy resulted in comparative
effects (5 year Disease free survival: 61.7% -70.2%; 5-year Overall survival: 66.4% -86.0%)
with significant lower 3/4 degrees of adverse events. As a compound combined with tegafur,
gimeracil and oteracil potassium in a molar ratio of 1: 0.4: 1, it plays an anti-tumor effect
as 5-Fu precursor drug, metabolized by liver cytochrome enzyme (P450) system into 5-Fu with
less toxicity. The addition of tegafur improves the anti-tumor activity by raising its oral
absorption. Gimeracil, as a potent and reversible inhibitor of dihydropyrimidine
dehydrogenase (DPD enzyme), largely increases the concentration of 5-Fu in blood and tumor
tissue, meanwhile reduces the 5-Fu no active metabolite fluoride-β-alanine (F-β-Ala)
production, leading to the decrease of cardiovascular and neural toxicity and the incidence
of hand-foot syndrome . Oteracil potassium specifically inhibits the intestinal mucosal cells
within the orotate phosphoribosyl transferase (OPRT enzyme), blocking 5-Fu phosphorylation,
reducing the digestive tract mucosal damage, thereby lowering the digestive tract toxicity.
Colorectal cancer patients who undergo curative surgery, are enrolled in this study, and
randomized into TGOP combined with oxaliplatin (TGOP-OX) and capecitabine combined with
oxaliplatin (XELOX) groups. The aim of the study is to confirm that the efficacy of TGOP-OX
group as adjuvant chemotherapy is not inferior to that of the XELOX group. Adverse reactions
will be systemically collected based on CTCAE 4.0 criteria for each cycle. The quality of
life was assessed by the European Cancer Research Organization questionnaires. Patients will
undergo close follow-up according to the NCCN recommendation. Minimum follow-up period is
designed as 3 years, and each endpoint will be evaluated as each check-point.
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