Trial reportRadiation oncology (London, England)2020
Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma.
Trial report in Radiation oncology (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 44 papers, 7 of them syntheses that pooled it.
What it found
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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.
Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma
Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.
A Prospective, Open-Label, Single-Arm and Multicentre Phase II Study to Explore the Efficacy and Safety of Neoadjuvant Cadonilimab Plus Chemotherapy Following Short-Course Radiotherapy in Middle and Lower Locally Advanced Rectal Cancer
Who cites it
44 citing papers in PubMed, 7 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Neoadjuvant chemoradiotherapy with or without PD-1 inhibitors in MMR-proficient non-metastatic rectal cancer: a meta-analysis of randomized controlled trials.Frontiers in immunology · 2026Pooled it
- Efficacy and safety of neoadjuvant therapy combined with immunotherapy in MMR‑proficient/microsatellite stable non‑metastatic rectal cancer: a systematic review and meta‑analysis.Journal of cancer research and clinical oncology · 2025Pooled it
- Neoadjuvant chemoradiotherapy with or without preoperative immunotherapy for locally advanced rectal cancer: a system review and meta-analysis.Updates in surgery · 2025Pooled it
- Neoadjuvant immunotherapy for DNA mismatch repair proficient/microsatellite stable non-metastatic rectal cancer: a systematic review and meta-analysis.Frontiers in immunology · 2025Pooled it
- The efficacy and safety of neoadjuvant treatment with the PD-1 inhibitor for locally advanced colorectal cancer: a meta-analysis.Frontiers in oncology · 2024Pooled it
- The efficacy and safety of neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced rectal cancer patients: a systematic review.Frontiers in immunology · 2024Pooled it
- Meta-analysis of neoadjuvant immunotherapy for non-metastatic colorectal cancer.Frontiers in immunology · 2023Pooled it
- Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer: 3-year survival from a phase 2 study.BMC medicine · 2025Trial
- Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial.Nature medicine · 2025Trial
- Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer.British journal of cancer · 2024Trial
- Trial
- Trial
- Metabolomics-based and functional validation to explore the effect of the gut microbe-associated metabolite guanidinoacetic acid on rectal adenocarcinoma.Scientific reports · 2026Article
- Review
- Meta-analysis of the efficacy of neoadjuvant immunotherapy combined with radiotherapy and chemotherapy for locally advanced rectal cancer.World journal of gastrointestinal oncology · 2025Article
- Short-Term Results of the SONCAR Study: Optimized Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer Patients.MedComm · 2025Article
- Controversies and Perspectives in the Current Management of Patients with Locally Advanced Rectal Cancer-A Systematic Review.Life (Basel, Switzerland) · 2025Review
- Organ Function Preservation in Locally Advanced Low Rectal Cancer Through Total Neoadjuvant Therapy: A Case Report and Literature Review.Cancer management and research · 2025Article
- Research progress on immunotherapy combined with neoadjuvant concurrent chemoradiotherapy in pMMR/MSS locally advanced rectal cancer.Frontiers in immunology · 2025Review
- CapeOX as neoadjuvant chemotherapy for locally advanced rectal cancer: might less be more?BMC cancer · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeoadjuvant chemotherapy and short-course radiotherapy followed by resection has been gaining recognition in the treatment of rectal cancer. Avelumab is a fully human immunoglobulin that binds Programmed Death-Ligand 1 (PD-L1) and prevents the suppression of the cytotoxic T cell immune response. This phase II trial evaluates the safety and pathologic response rate of short-course radiation followed by 6 cycles of mFOLFOX6 with avelumab in patients with locally advanced rectal cancer (LARC).
methodsThis study is prospective single-arm, multicenter phase II trial adopting Simon's two-stage. Short-course radiation is given over 5 fractions to a total dose of 25 Gy. mFOLFOX6 plus avelumab (10 mg/kg) are given every 2 weeks for 6 cycles. Total mesorectal excision is performed 3-4 weeks after the last cycle of avelumab. Follow up after surgery is done every 3 months to a total of 36 months. Adverse event data collection is recorded at every visit.
results13 out of 44 patients with LARC were enrolled in the first stage of the study (30% from total sample size). All patients met the inclusion criteria and received the full short-course radiation course followed by 6 cycles of mFOLFOX6 plus avelumab. 12 out of the 13 patients completed TME while one patient had progression of disease and was dropped out of the study. The sample consisted of 9 (69%) males and 4 (31%) females with median age of 62 (33-73) years. The first interim analysis revealed that 3 (25%) patients achieved pathologic complete response (pCR) (tumor regression grade, TRG 0) out of 12. While 3 (25%) patients had near pCR with TRG 1. In total, 6 out of 12 patients (50%) had a major pathologic response. All patients were found to be MMR proficient. The protocol regimen was well tolerated with no serious adverse events of grade 4 reported.
conclusionIn patients with LARC, neoadjuvant radiation followed by mFOLFOX6 with avelumab is safe with a promising pathologic response rate. Trial Registration Number and Date of Registration ClinicalTrials.gov NCT03503630, April 20, 2018. https://clinicaltrials.gov/ct2/show/NCT03503630?term=NCT03503630&draw=2&rank=1 .
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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.