SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.
Eligibility criteria
Qualifiers
Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma.
Primary tumor located ≤18 cm from margin verge.
Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm).
≥ 18 years of age.
Disqualifiers
Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).
Synchronous cancer found on colonoscopy.
Previous history of pelvic radiotherapy.
History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years.
Trial design
Treatments tested in this trial
- Intensity-modulated radiation therapy
- 5-fluorouracil
- Leucovorin
- Oxaliplatin
- Capecitabine
- Accelerated Radiation Therapy
- Irinotecan
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov