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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
Long course CRT is followed by 4 cycles of combination chemotherapy of modified FOLFOX6 or 3 cycles of XELOX (capecitabine and oxaliplatin) and then surgery
King Abdullah Medical City, Holy Capital
Mecca, Makkah Western, Saudi Arabia
RECRUITINGPathologic complete response rate (pCR).
pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (ypT0N0) by histopathological assessment of the surgical specimen at the time of definitive rectal surgery.
Time frame: 3 years
3-year disease free survival (DFS) rate.
3-year DFS will be defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of randomization
Time frame: 3 years
Overall survival (OS)
defined as the time from randomization to death from any cause
Time frame: 5 years
Radiological response by MRI imaging before surgery.
Time frame: 3 years
Short and long-term toxicity.
According to common toxicology criteria of adverse events, version 3
Time frame: 3 - 5 years
Surgical complications.
Time frame: 3 years
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