Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients (NCT02891538) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients
United States51 participantsStarted 2017-01-31
Plain-language summary
This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cytologically or histologically confirmed of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer.
* Age 18 years and above
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* The patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, and there is a planned surgery for the primary colorectal cancer cancer or the patient had recent resection of the primary colorectal cancer. .
* For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception. For men: agreement to use a barrier method of contraception during the treatment period
* Hematologic, Biochemical, and Organ Function within 7 days prior to Cycle 1 Day 1: Granulocyte count \> 1000/mm3, Platelet count \> 50,000/ mm3, Hemoglobin \> 7 g/dL; Total bilirubin \< 1.5xULN; Albumin \> 2.8g/dl; aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) \</=2.5 x upper limit of normal (ULN); Serum creatinine\< 2 x ULN
Exclusion Criteria:
* Patients receiving prior chemotherapy or chemoradiation for colorectal cancer (ie, neoadjuvant chemoradiation for stage II or III rectal cancer).
* Known diagnosis of stage III colon or rectal cancer will be excluded from the study.
* Patients with metastatic disease.
* Patients may not be receiving any other investigational age…
What they're measuring
1
Change in methylation from baseline when compared to the control arm
Timeframe: 1 year
Trial details
NCT IDNCT02891538
SponsorThe University of Texas Health Science Center at San Antonio