Trial reportInternational journal of radiation oncology, biology, physics2024
Compliance and Toxicity of Total Neoadjuvant Therapy for Rectal Cancer: A Secondary Analysis of the OPRA Trial.
Trial report in International journal of radiation oncology, biology, physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- 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
- Trial
- Identification of Factors That Determine Adherence for Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer.Cancers · 2026Article
- Safety and Tolerability of Different Total Neoadjuvant Therapies in Patients With Locally Advanced Rectal Cancer.Cancer medicine · 2026Article
- Organ preservation with total neoadjuvant therapy in early-stage rectal cancer: A statewide analysis.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026Article
- Impact of total neoadjuvant therapy regimens on radiation-induced lymphopenia in locally advanced rectal cancer: a retrospective analysis.Journal of radiation research · 2025Article
- Total neoadjuvant therapy in early-onset rectal cancer: A multicentre prospective cohort study.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025Article
- ASO Perspective Regarding Issues by the Phase II OPRA Trial and Rectal Adenocarcinoma Treated with Total Neoadjuvant Therapy.Annals of surgical oncology · 2024Article
- Assessing the OPRA Trial for surgical oncologists: Safety and feasibility of a total neoadjuvant therapy approach in patients with rectal cancer.Surgical oncology insight · 2024Article
- Treatment Options for Distal Rectal Cancer in the Era of Organ Preservation.Current treatment options in oncology · 2024Review
- Nonoperative management of rectal cancer.Frontiers in oncology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
purposePatients with locally advanced rectal cancer treated with total neoadjuvant therapy (TNT) may achieve organ preservation without a compromise to oncologic outcomes. However, reports on patient compliance with TNT and with treatment-related toxicities are limited. METHODS AND MATERIALS: The OPRA trial assessed organ preservation rates and oncologic outcomes in patients with clinical stage II/III rectal adenocarcinoma randomized to induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Systemic chemotherapy consisted of 8 cycles (16 weeks) of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or 5 cycles (15 weeks) of capecitabine and oxaliplatin (CAPEOX). Patients received >4500 cGy of radiation with sensitizing capecitabine or fluorouracil. In this report, we compare compliance and treatment-related toxicity in patients receiving INCT-CRT versus CRT-CNCT. Additionally, we evaluate the association of compliance to chemotherapy, compliance to chemoradiation, and toxicity with organ preservation and disease-free survival (DFS).
resultsOf the 324 patients randomized, fewer patients started chemoradiation in the INCT-CRT group compared with the CRT-CNCT group (93% vs 98%, P = .03), and fewer patients started systemic chemotherapy in the CRT-CNCT group compared with the INCT-CRT group (94% vs 99%, P = .04). Order of TNT did not affect the ability to complete all intended cycles of FOLFOX (86% INCT-CRT vs 83% CRT-CNCT, P = .60) or CAPEOX (74% INCT-CRT vs 77% CRT-CNCT, P = .80). A total of 97% of INCT and 98% of CRT-CNCT patients received >4500 cGy radiation (P = .93). Sixty-four patients (41%) treated with INCT-CRT and 57 CRT-CNCT patients (34%) experienced a grade 3+ adverse event (P = .30). Compliance and toxicity were not associated with organ preservation or DFS.
conclusionsWe identified only minor differences in treatment compliance between patients treated with INCT-CRT and CRT-CNCT. No difference in adverse events was observed between groups. Treatment compliance and toxicity did not correlate with organ preservation rates or DFS.
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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.