SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients (NCT03448549) | Clinical Trial Compass
UnknownPhase 3
SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
China1,191 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3 year disease free survival
Timeframe: 3 years
Trial details
NCT IDNCT03448549
SponsorPeking University Cancer Hospital & Institute