Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
72 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Systematic review of patient-reported outcome item libraries in cancer research: an EORTC Quality of Life Group study.Journal of the National Cancer Institute · 2026Pooled it
- Research trends and hotspots of circulating tumor DNA in colorectal cancer: a bibliometric study.Frontiers in oncology · 2025Pooled it
- Nutritional Prehabilitation Intervention in Hematological Patients Undergoing Bone Marrow Transplant: A Systematic Review of the Literature.Nutrients · 2024Pooled it
- Pilot Randomized Trial of a Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer.Journal of pain and symptom management · 2026Trial
- Clinical Benefit and Cost-Effectiveness of FOLFOX Versus LCCRT in Neoadjuvant Treatment for Patients with Locally Advanced Rectal Cancer: An Economic Analysis of the FOWARC and PROSPECT Trial.Annals of surgical oncology · 2026Trial
- Effect of ADOPT model-based nursing intervention on self-management ability in patients with middle and low rectal cancer after sphincter-preserving surgery.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Trial
- Impact of neoadjuvant treatment on functional outcomes after transanal total mesorectal excision (taTME)-a case series.Surgical endoscopy · 2025Trial
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- Trial
- Chemoradiotherapy plus induction or consolidation chemotherapy as total neoadjuvant therapy for locally advanced rectal cancer: Pooled analysis of the CAO/ARO/AIO-12 and the OPRA randomized phase 2 trials.European journal of cancer (Oxford, England : 1990) · 2024Trial
- Trial
- Preoperative Treatment of Locally Advanced Rectal Cancer.The New England journal of medicine · 2023Trial
- Distal Resection Margin Collagen Score to Predict Major Low Anterior Resection Syndrome After Neoadjuvant Chemoradiotherapy in Rectal Cancer.Annals of surgical oncology · 2026Article
- Network temperature and stability of symptom clusters in colorectal cancer patients undergoing adjuvant chemotherapy: a prospective longitudinal study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Observational
- Oral and gut microbiota profiles in patients with locally advanced rectal cancer with varying responses to neoadjuvant chemoradiotherapy.Functional & integrative genomics · 2026Observational
- Report from the 27th Annual Western Canadian Gastrointestinal Cancer Consensus Conference on Colorectal Cancer, Calgary, Alberta, 26-27 September 2025: Advances in Colon and Rectal Cancer.Current oncology (Toronto, Ont.) · 2026Article
- The CHRONO trial: Protocol for a randomized controlled trial of early time-restricted eating in patients with breast or rectal cancer.Nutrition research (New York, N.Y.) · 2026Article
- A Consensus Approach to the Incorporation of Total Neoadjuvant Therapy in a Treatment Algorithm for Stage I-III Resectable Rectal Cancer.Current oncology (Toronto, Ont.) · 2026Review
- Personalised neoadjuvant therapy, based on tumour characteristics and patient choice, is the best way forward in rectal cancer.Journal of gastrointestinal oncology · 2026Article
- Association Between Radiotherapy (±Chemotherapy) and the Severity of Low Anterior Resection Syndrome After Rectal Cancer Surgery: Does Radiotherapy Separate Risk?Medical sciences (Basel, Switzerland) · 2026Observational
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 12 institutions in 1 country.
Funding
Abstract
purposeThe standard of care for locally advanced rectal cancer in North America is neoadjuvant pelvic chemoradiation with fluorouracil (5FUCRT). Neoadjuvant chemotherapy with fluorouracil and oxaliplatin (FOLFOX) is an alternative that may spare patients the morbidity of radiation. Understanding the relative patient experiences with these options is necessary to inform treatment decisions.
methodsPROSPECT was a multicenter, unblinded, noninferiority, randomized trial of neoadjuvant FOLFOX versus 5FUCRT, which enrolled adults with rectal cancer clinically staged as T2N+, cT3N-, or cT3N+ who were candidates for sphincter-sparing surgery. Neoadjuvant FOLFOX was given in six cycles over 12 weeks, followed by surgery. Neoadjuvant 5FUCRT was delivered in 28 fractions over 5.5 weeks, followed by surgery. Adjuvant chemotherapy was suggested but not mandated in both groups. Enrolled patients were asked to provide patient-reported outcomes (PROs) at baseline, during neoadjuvant treatment, and at 12 months after surgery. PROs included 14 symptoms from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Additional PRO instruments measured bowel, bladder, sexual function, and health-related quality of life (HRQL).
resultsFrom June 2012 to December 2018, 1,194 patients were randomly assigned, 1,128 initiated treatment, and 940 contributed PRO-CTCAE data (493 FOLFOX; 447 5FUCRT). During neoadjuvant treatment, patients reported significantly lower rates of diarrhea and better overall bowel function with FOLFOX while anxiety, appetite loss, constipation, depression, dysphagia, dyspnea, edema, fatigue, mucositis, nausea, neuropathy, and vomiting were lower with 5FUCRT (all multiplicity adjusted
conclusionFor patients with locally advanced rectal cancer choosing between neoadjuvant FOLFOX and 5FUCRT, the distinctive PRO profiles inform treatment selection and shared decision making.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.