Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT04677413|
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : September 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Ultrafractionated radiotherapy for rectal cancer||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective dose evaluation|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer|
|Actual Study Start Date :||June 3, 2021|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||June 2026|
Experimental: Phase I Dose Cohorts
DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)
Radiation: Ultrafractionated radiotherapy for rectal cancer
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.
- To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT. [ Time Frame: 0 to 60 days post radiation therapy ]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.
- To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy. [ Time Frame: 1 year ]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 4.11.
- To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy. [ Time Frame: 1 year ]Organ preservation rate will be defined as rate of intact rectum and no local regional failure at 1 year from completion of treatment.
- To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression. [ Time Frame: 1 year ]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.
- To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death. [ Time Frame: 1 year ]The disease-free survival endpoint will be defined as the percent of patients without disease recurrence at 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. [ Time Frame: 1 year ]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.
- To evaluate the rate of distant failure, defined as development of disease outside of the pelvis. [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677413
|Contact: Sarah Hardeeemail@example.com|
|Contact: Kajal Desaifirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-8849|
|Contact: sarah Hardee 214-645-8525 sarah.neufeld@UTSouthwestern.edu|
|Principal Investigator: Nina Sanford, M.D.|
|Principal Investigator:||Nina Sanford, MD||UT SOUTHWESTERN medical CENTRE|