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Neoadjuvant chemotherapy with FOLFOX without preoperative chemoradiation therapy (for select patients with lower-risk disease)
Source: Rectal Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 12, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.
Context: Treatment of Stages II and III Rectal Cancer / Treatment Options for Stages II and III Rectal Cancer
Evidence (neoadjuvant chemotherapy with FOLFOX without preoperative chemoradiation therapy [for select patients with lower-risk disease]):
The PROSPECT trial (NCT01515787) included 1,194 patients with clinical T2, node-positive; T3, N0; or T3, node-positive rectal cancer who were candidates for sphincter-sparing surgery. A total of 1,128 patients were randomly assigned to receive either neoadjuvant FOLFOX (six cycles) or chemoradiation therapy.[1][Level of evidence B1]
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The PROSPECT trial (NCT01515787) included 1,194 patients with clinical T2, node-positive; T3, N0; or T3, node-positive rectal cancer who were candidates for sphincter-sparing surgery. A total of 1,128 patients were randomly assigned to receive either neoadjuvant FOLFOX (six cycles) or chemoradiation therapy.[1][Level of evidence B1]
Patients in the neoadjuvant FOLFOX group who had less than 20% clinical response upon restaging, or who were unable to tolerate at least five cycles of FOLFOX were selected to receive chemoradiation therapy. Neoadjuvant FOLFOX with only selective use of pelvic chemoradiation therapy was noninferior to up-front neoadjuvant pelvic chemoradiation therapy for DFS (hazard ratio [HR]disease recurrence or death, 0.92; 90.2% confidence interval [CI], 0.74–1.14; P = .005 for noninferiority).[1]
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These results show that using six cycles of FOLFOX instead of neoadjuvant chemoradiation therapy is an acceptable option for this patient population, which is considered to represent potentially over one-half of all patients with locally advanced rectal cancer in the United States. Avoidance of chemoradiation therapy could potentially spare patients from long-term side effects, such as impairment in bowel, bladder and sexual function, increased risk of pelvic fractures and secondary malignancies, decreased bone marrow reserve, and fertility impacts.
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Preserved source evidence · Independent clinical review pending · Not medical advice