Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

  • STATUS
    Recruiting
  • End date
    May 21, 2027
  • participants needed
    1370
  • sponsor
    Fudan University
Updated on 21 January 2021
Investigator
Sanjun Cai, M.D
Primary Contact
Department of Colorectal Surgery Fudan University Shanghai Cancer Center (2.3 mi away) Contact

Summary

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. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.

Details
Condition Locally Advanced Colon Cancer
Treatment capecitabine plus oxaliplatin before and after surgery, capecitabine plus oxaliplatin after surgery
Clinical Study IdentifierNCT03125980
SponsorFudan University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion 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 count1.5109/L, Platelet count100109/L, Hemoglobin80g/L, Serum bilirubin24umol/L, Alanine aminotransferase and aspartate aminotransferase 60IU/L, Serum creatinine110 umol/L
No current pregnancy or breast-feeding, and subjects 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

Exclusion Criteria

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 psychiatric historysevere infection; active disseminated intravascular coagulation
Unable or unwilling to abide by the study plan
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