Phase II/III Study to Assess the Efficacy of Neoadjuvant Consolidation Chemotherapy in Rectal Cancer Patients.
Status:
Recruiting
Trial end date:
2025-11-23
Target enrollment:
Participant gender:
Summary
This is a Phase II/III randomized study involving non-metastatic rectal cancer patients who
are candidates for neoadjuvant chemoradiotherapy. Eligible patients will be randomized
between two treatment arms:
Experimental arm: Long course CRT is followed by 4 cycles of combination chemotherapy of
modified FOLFOX6 or 3 cycles of XELOX and then surgery. After surgery, patients with pT0-2 N0
will not receive adjuvant chemotherapy. Patients with higher pathological stage will receive
adjuvant chemotherapy (4 cycles of modified FOLFOX6 or 3 cycles of XELOX).
Standard arm: Long course CRT will be followed by surgery 10-12 weeks after the end of CRT.
After surgery, patients with pT0-2 N0 will not receive adjuvant chemotherapy. Patients with
higher pathological stage will receive adjuvant chemotherapy (8 cycles of modified FOLFOX6 or
6 cycles of XELOX).
The study aims to assess the efficacy of consolidation chemotherapy given in the interval
between the end of CRT and surgery to allow for early initiation of systemic therapy aiming
to decrease distant relapse rate and enhancing pathological response.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
King Abdullah Medical City
Collaborators:
Al Hada Military Hospital King Faisal Specialist Hospital & Research Center King Saud Medical City