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About
The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
Full description
These patients will be evaluated for complete clinical response (cCR) after completing 10 cycles of FOLFOX (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be treated per discretion of the treating physician following multidisciplinary discussion. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.
Enrollment
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Volunteers
Inclusion criteria
Participants must be >18 years old at time of diagnosis
Histologically confirmed adenocarcinoma of the rectum from biopsy, defined as adenocarcinoma <15 cm from the anal verge
Clinical staging including T3N0 tumors, or T1-3 with N1-2a disease
Patients with lower rectal cancer deemed by surgery to not be candidates for sphincter sparing surgery are eligible to participate
There must be no evidence of metastatic disease any time prior to initiation of study
Rectal tumors must be determined as likely requiring total mesorectal excision (TME)
Participant must be treatment naïve for rectal cancer, with no prior radiation chemotherapy, radiation, or surgery for specific rectal cancer
No history of prior pelvic radiation
No prior administration of platinum agents
No active infections requiring intravenous antibiotics
No additional active malignancy
No prior treatment of any malignancy within the past 3 years
Baseline lab work must meet the following parameters:
Women of childbearing potential (WCBP) will be defined as those biologically capable of becoming pregnant. WCBP must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study.
Participants must be read and explained the purposes of the study, and sign a statement of informed consent prior to participation. Those who do not read or understand English are eligible and may be consented according to institutional federal regulations.
Exclusion criteria
aCTCAE version 5.0 from Department of Health and Human Services
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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