Adaptive Radiation Boost for Rectal Cancer
ConditionRectum Cancer, Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.
The main questions the study aims to answer are:
* Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue? * Can it reduce the side effects that people may experience during treatment?
Participants will:
* First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine. * Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds. * Use a small balloon during treatment to help aim the radiation and protect healthy areas. * Finally, receive additional chemotherapy (such as FOLFOX) for four months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.
Subjects must be willing to undergo MRI scans.
Age ≥18 years.
Disqualifiers
Subjects who have been previously treated for rectal cancer are excluded.
Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
Subjects must not be receiving any other investigational agents.
Subjects may not have had prior pelvic radiation.
Trial design
Design model
Single group
Treatments tested in this trial
Adaptive Radiotherapy Boost
RadiationPatients will receive one boost fraction every two weeks, targeting the primary tumor within the rectum plus a 2 mm Planning Target Volume (PTV) margin. Any regional lymph nodes that measure at least 5 mm in short axis on the day of treatment will receive treatment with the ART dose being given to the primary rectal tumor.
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Adaptive Radiotherapy Boost Following Standard Pelvic ChemoradiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD will be evaluated by monitoring the rate of dose limiting toxicities (DLTs) defined as acute Grade 2+ gastrointestinal toxicity probably or definitely related to radiation.
Time frame
From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days.2
Feasibility of a rectal boost that targets at least 90% of the rectal planning tumor volume with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc.
Feasibility will be determined based on successful implementation and completion of standard chemoradiotherapy followed by experimental rectal adaptive radiotherapy boost utilizing CT-MR fusion that targets at least 90% of the rectal PTV\_Eval with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc in ≥ 70% of ART fractions for the patient population enrolled in the study. This will be assessed at the MTD.
Time frame
From the ART boost initiation to the end of the ART boost, for a period of ~ 5 weeksSecondary outcomes
1
Estimate the efficacy of bi-weekly adaptive radiotherapy boost fractions by complete response rate, near complete response rate, and incomplete response rate as per Memorial Sloan Kettering Cancer Center (MSKCC) criteria.
Time frame
From the end of rectal adaptive radiotherapy boost to the end of study, for a total of ~ 5 years.2
Estimate total mesorectal excision (TME) free survival following treatment with the study regimen.
Time frame
From the end of treatment to the end of the study, for a total of up to 5 years.3
Estimate overall survival (OS) following treatment with the study regimen.
Time frame
From the end of treatment to the end of study, for a total of up to 5 years.4
Estimate early and late toxicity following treatment with the study regimen.
Time frame
From the initiation of rectal radiation boost treatment to the end of the study, for a total of ~ 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fox Chase Cancer Center
Lead sponsor
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov