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
Qualifiers
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
Treatments tested in this trial
- Adaptive Radiotherapy Boost
Treatment groups
37 Participants
are divided into 1 treatment groupSponsors and collaborators
Fox Chase Cancer Center
Lead sponsor
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov