Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Eligibility criteria
Qualifiers
Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy
Colonoscopy, unless patient presents with an obstructing lesion
History/physical examination
Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI
Disqualifiers
Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
Serious (ie, ≥ grade 3) uncontrolled infection
Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
Trial design
Treatments tested in this trial
- Chemotherapy
- Radiation Therapy
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov