Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 545 papers, 11 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.
Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial
The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.
Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol
Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02). An Interventional Study.
Who cites it
545 citing papers in PubMed, 11 syntheses or guidelines pooled it, 843 citations in OpenAlex.
- A systematic review and meta-analysis of preoperative MRI-based pelvimetry in predicting surgical difficulty in rectal cancer: Implications for personalised surgical planning.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026Pooled it
- Methodological challenges in surgical randomized trials: systematic review of rectal cancer studies.BJS open · 2026Pooled it
- Pooled it
- Immune-inflammatory indices as predictors of pathologic complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a systematic review and meta-analysis of observational studies.World journal of surgical oncology · 2026Pooled it
- SEOM-GEMCAD-TTD clinical guidelines for localized rectal cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- Is radical surgery always necessary in early rectal cancer? A systematic review of randomised trials.Surgical endoscopy · 2026Pooled it
- Watch-and-Wait strategy for locally advanced rectal cancer after neoadjuvant chemoradiotherapy: a comprehensive review.Frontiers in oncology · 2026Pooled it
- Neoadjuvant therapy combined with immunotherapy for anal sphincter preservation rate, clinical efficacy, and safety in rectal cancer patients: a meta-analysis.Frontiers in oncology · 2026Pooled it
- Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2024 for the treatment of colorectal cancer.International journal of clinical oncology · 2025Guideline
- Compliance and Toxicity of Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Systematic Review and Network Meta-analysis.Annals of surgical oncology · 2025Pooled it
- Optimal choice of different neoadjuvant chemoradiotherapies for locally advanced rectal cancer: systematic review and network meta-analysis.Cancer metastasis reviews · 2025Pooled it
- Pilot Randomized Trial of a Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer.Journal of pain and symptom management · 2026Trial
- A multicohort, biomarker-driven phase 2 trial of personalized total neoadjuvant therapy with targeted agents for high-risk rectal cancer (The TRAINER study).Signal transduction and targeted therapy · 2026Trial
- Prioritizing Chemotherapy in Total Neoadjuvant Therapy Improves pCR Rate in Locally Advanced Rectal Cancer in Countries with Limited Radiotherapy Access: A Randomized Controlled Trial.Journal of gastrointestinal cancer · 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
- Effects of stoma discharge reinfusion on low anterior resection syndrome and the gut microbiota following sphincter-preserving surgery for middle and low rectal cancer: a randomized clinical trial.Updates in surgery · 2026Trial
- Diagnostic accuracy and pitfalls of MRI for restaging locally advanced rectal cancer in patients following anti-PD1 therapy plus neoadjuvant chemoradiotherapy: a multicenter study.Abdominal radiology (New York) · 2026Trial
- Intergroup randomized phase III study of adjuvant FOLFIRI, FOLFOX, or 5-FU/leucovorin for stage II/III rectal cancer: ECOG-ACRIN E3201.The oncologist · 2025Trial
- Neoadjuvant chemoradiotherapy with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer: 5-year update of the CinClare trial.Cancer communications (London, England) · 2025Trial
- Association of Lateral Pelvic Lymph Nodes with Disease Recurrence and Organ Preservation in Patients with Distal Rectal Adenocarcinoma Treated with Total Neoadjuvant Therapy.Annals of surgery · 2025Trial
485 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
42 authors at 20 institutions in 1 country.
Funding
Abstract
purposeProspective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited.
methodsIn this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival.
resultsMedian follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates.
conclusionOrgan preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.