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Compares treatment options for Locally Advanced Colon Cancer
Official title Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer
ClinicalTrials.gov ID: NCT03125980
What this study is testing
What is capecitabine plus oxaliplatin before and after surgery?
capecitabine plus oxaliplatin before and after surgery is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study...
- No current pregnancy or breast-feeding, and people at childbearing age shall take method of contraception ;
- Be in a condition to receive a surgery/procedure;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
You likely can't join if
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
- Metastatic carcinoma;
- Moderate or above anemia caused by serious local tumor bleeding;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to oxaliplatin or capecitabine;
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L...
- No current pregnancy or breast-feeding, and people at childbearing age shall take method of contraception ;
- Be in a condition to receive a surgery/procedure;
- No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
- No previous systemic chemotherapy for treating colon cancer;
- No other chemotherapy at the same time;
- Expected lifetime longer than three months;
- Be willing and able to understand the study and to provide written informed consent.
- End-stage cachexia patients;
- Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
- Metastatic carcinoma;
- Moderate or above anemia caused by serious local tumor bleeding;
- Incomplete or complete intestinal obstruction;
- Known to be allergic to oxaliplatin or capecitabine;
- Active hepatitis, severe coagulation disorder patients;
- Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
- Known to have deficient dihydropyrimidine dehydrogenase (DPD)；
- Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or...
- Unable or unwilling to abide by the study plan.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.