# PROSPECT (Alliance N1048)

Source: https://onco.cc/trials/prospect/  
OnCo record `prospect` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

PROSPECT showed that most people with intermediate-risk rectal cancer can skip pelvic radiotherapy altogether: chemotherapy alone before surgery, with radiotherapy held back for the few whose tumours did not shrink, cured just as many.

## Summary

PROSPECT randomised 1,194 patients with rectal cancer that was locally advanced but not threatening the mesorectal fascia or the sphincter to six cycles of neoadjuvant FOLFOX, with chemoradiation given only if the tumour shrank by less than 20 percent, or to standard fluoropyrimidine chemoradiation. Both groups then had total mesorectal excision and adjuvant chemotherapy.

Five-year disease-free survival was 80.8 percent with FOLFOX and 78.6 percent with chemoradiation, meeting the non-inferiority margin; only 9 percent of the FOLFOX group needed chemoradiation. Local recurrence and overall survival were no different, and patient-reported bowel, sexual and neuropathy outcomes favoured different arms at different times.

The trial removed radiotherapy from the default pathway for a large group of rectal cancer patients and, with RAPIDO, PRODIGE 23 and OPRA, made the treatment of rectal cancer a choice of sequences tailored to risk and to the goal of organ preservation.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT01515787
- Phase: 2/3
- Setting: cT2 node-positive, cT3 node-negative or cT3 node-positive rectal cancer suitable for sphincter-sparing surgery: FOLFOX with chemoradiation only for poor responders, versus standard pelvic chemoradiation before surgery
- Sponsor: Alliance for Clinical Trials in Oncology / NCI
- Enrolled: 1194
- Result: 5-year disease-free survival 80.8% (FOLFOX, selective chemoradiation) vs 78.6% (chemoradiation), non-inferior; 9% of the FOLFOX arm received chemoradiation.
- Outcomes: Disease-free survival at 5 years: FOLFOX with selective chemoradiation 80.8% vs Chemoradiation 78.6%, HR 0.92
- Replication: The Chinese FOWARC trial had earlier reported similar disease control with FOLFOX alone; national guidelines in the US and Europe added the chemotherapy-first option in 2023 and 2024.

## Sources

- ClinicalTrials.gov NCT01515787: https://clinicaltrials.gov/study/NCT01515787
- New England Journal of Medicine 2023: https://doi.org/10.1056/NEJMoa2303269

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- institutions: [Alliance for Clinical Trials in Oncology](https://onco.cc/institutions/alliance-oncology/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/), [Total mesorectal excision (TME)](https://onco.cc/terms/total-mesorectal-excision/)

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