The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
To determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery.
UT Southwestern Medical Center
Dallas, Texas, United States
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.
Time frame: 0 to 60 days post radiation therapy
To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy.
Clinical complete response, assessed at 4-8 weeks after completion of chemotherapy and radiation, will be defined based upon endoscopy and MRI as described in section 4.1.1.
Time frame: 1 year
To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy.
Organ preservation rate will be defined as rate of intact rectum and no local regional failure at 1 year from completion of treatment.
Time frame: 1 year
To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression.
The rate of local regional recurrence will be defined as disease recurrence in the pelvis and will be recorded on a time interval since completion of treatment. This will be evaluated as a median and rate up to 1 year post treatment. The time will be backdated to when the recurrence was observed.
Time frame: 1 year
To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death.
The disease-free survival endpoint will be defined as the percent of patients without disease recurrence at 1-year.
Time frame: 1 year
For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.
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R0 resection will be defined by the percent of patients with an R0 resection or negative surgical margin at the time of total mesorectal excision. Acute and late toxicities will be recorded as the rate of treatment related grade 3-5 adverse events experienced in the acute phase from initiation of therapy to 6 weeks treatment to the late phase 6 weeks to 1 year, using the NCI's CTCAE v5.0 toxicity criteria.
Time frame: 1 year
To evaluate the rate of distant failure, defined as development of disease outside of the pelvis.
The rate of distant failure will be recurrence of disease outside of the pelvis that will be collected on time interval since completion of therapy and be evaluated as a median or rate up to 1-year follow-up. Time will be backdated to when the recurrence was observed.
Time frame: 1 year