Total Neoadjuvant Therapy Versus Standard Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Status:
Completed
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The National Comprehensive Cancer Network (NCCN) guidelines recommend trimodality treatment
for patients with middle and low LARC with neoadjuvant chemoradiotherapy (NA-CRT), surgical
resection with TME, plus additional chemotherapy (CT), in the adjuvant setting. This has
markedly reduced pelvic local recurrence from historically about 25% to about 5-10%. However,
the 5-year distant relapse is approximately 30% and continues to be the major cause of rectal
cancer death.
One strategy to address this issue is to deliver induction chemotherapy before surgery.
Induction chemotherapy may be associated with better treatment compliance and may enable full
systemic doses of chemotherapy to be delivered.
The above cited considerations, plus favorable data from preliminary reports exploring this
strategy, provides a solid rationale for shifting systemic treatment earlier into the
treatment paradigm. The current study will evaluate the efficacy and the safety of total
neoadjuvant therapy with standard neoadjuvant chemoradiotherapy for locally advanced rectal
cancer patients as regards effects on tumor downstaging, pathological complete response,
surgical difficulty and early functional outcome.