A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in
patients with locally advanced rectal cancer (LARC) because of increased local control,
enhanced sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor
and reduced local recurrence. However, survival benefit of NCRT has not been demonstrated
and the rate of distant metastasis was still reported as high as 30%.
Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival
benefit. We inferred that additional chemotherapy during the resting period could enhance
the pCR rate. The aim of the present study is to evaluate the safety and efficacy of an
additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in
patients with LARC.
Observational Model: Case-Only, Time Perspective: Prospective
Ji Yeon Kim, MD., PhD
Surgical Oncology Research Lab
South Korea: Korea Food and Drug Administration (KFDA)