Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2012
Cetuximab plus cisplatin, irinotecan, and thoracic radiotherapy as definitive treatment for locally advanced, unresectable esophageal cancer: a phase-II study of the SWOG (S0414).
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04846309 (Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.
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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.
Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Esophageal cancer practice guidelines 2017 edited by the Japan Esophageal Society: part 1.Esophagus : official journal of the Japan Esophageal Society · 2019Guideline
- Interventions for dysphagia in oesophageal cancer.The Cochrane database of systematic reviews · 2014Pooled it
- Dose-escalated radiotherapy with PET/CT based treatment planning in combination with induction and concurrent chemotherapy in locally advanced (uT3/T4) squamous cell cancer of the esophagus: mature results of a phase I/II trial.Radiation oncology (London, England) · 2021Trial
- Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2020Trial
- Phase II study of concurrent chemoradiotherapy with a modified target volumes delineation method for inoperable oesophagealcancer patients.The British journal of radiology · 2017Trial
- Preoperative cetuximab, irinotecan, cisplatin, and radiation therapy for patients with locally advanced esophageal cancer.The oncologist · 2013Trial
- Salvage esophagectomy for unresectable locally advanced esophageal squamous cell carcinoma: Significant or not?Annals of gastroenterological surgery · 2025Review
- Consolidation Chemotherapy Provided Survival Benefit for Esophageal Squamous Cell Carcinoma Patients Who Underwent Concurrent Chemoradiotherapy Lower Than 60 Gy.Thoracic cancer · 2025Article
- Esophageal cancer practice guidelines 2022 edited by the Japan esophageal society: part 1.Esophagus : official journal of the Japan Esophageal Society · 2023Article
- Clinical Prognostic Factors for Patients With Esophageal Cancer Treated With Definitive Chemoradiotherapy.Cureus · 2021Article
- Treatment of esophageal cancer with multiple liver metastases: a case experience of sustained complete response.The Journal of international medical research · 2020Article
- Article
- Targeted Therapies for Targeted Populations: Anti-EGFR Treatment forCancer discovery · 2018Article
- Successes and Failures of Combined Modalities in Upper Gastrointestinal Malignancies: New Directions.Seminars in radiation oncology · 2016Review
- Targeted therapy in gastroesophageal cancers: past, present and future.Gastroenterology report · 2015Article
- EGFR targeted therapies and radiation: Optimizing efficacy by appropriate drug scheduling and patient selection.Pharmacology & therapeutics · 2015Review
- RNA interference for epidermal growth factor receptor enhances the radiosensitivity of esophageal squamous cell carcinoma cell line Eca109.Oncology letters · 2015Article
- Esophageal cancer management controversies: Radiation oncology point of view.World journal of gastrointestinal oncology · 2014Review
- Proteasome inhibitor MG132 inhibits the proliferation and promotes the cisplatin-induced apoptosis of human esophageal squamous cell carcinoma cells.International journal of molecular medicine · 2014Article
- Clinical prognostic factors for locally advanced esophageal squamous carcinoma treated after definitive chemoradiotherapy.Cancer research and treatment · 2013Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
introductionThe specific aims of the study were to evaluate the 2-year overall survival (OS) and progression-free survival (PFS), toxicity profile, and best objective response rate in patients with locally advanced, clinically unresectable esophageal cancer receiving cetuximab, cisplatin, irinotecan, and thoracic radiotherapy (TRT) within a multi-institutional cooperative-group setting.
methodsEligible patients (cT4 M0 or medically unresectable, biopsy proven, and noncervical esophageal cancer) were to receive four 21-day cycles of cetuximab 400 mg/m (day 1, cycle 1), cetuximab 250 mg/m (day 8, 15, cycle 1; then days 1, 8, and 15 for subsequent cycles), cisplatin 30 mg/m (days 1 and 8, all cycles), and irinotecan 65 mg/m (days 1 and 8, all cycles). TRT was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, to begin with on day 1 of cycle 3. The primary endpoint was 2-year OS, with an accrual goal of 75 patients with adenocarcinoma.
resultsThe study was closed because of slow accrual, with 21 eligible patients (11 squamous, 10 adenocarcinoma) enrolled from May 2005 to September 2007. Two-year OS and PFS (95% confidence interval [CI]) were 33.3% (14.6-57.0%) and 23.8% (8.2-47.2%), respectively. Kaplan-Meier estimates of median (95% CI) OS and PFS were 11.2 (6.4-43.6) and 6.4 (3.7-12.0) months, respectively. The overall response rate (95% CI) among 17 evaluable patients was 17.6% (3.8-43.4%), including 6% confirmed complete responders and 12% unconfirmed partial responders. Two deaths resulted from protocol treatment (sudden death and gastrointestinal necrosis). Ten (47.6%) and 6 (28.6%) patients had grade-3 or -4 toxicity, respectively: 52.4% were hematologic, 23.8% had fatigue, 19.0% had nausea, 19.0% had dehydration, and 19.0% had anorexia.
conclusionsConcomitant cetuximab, cisplatin, irinotecan, and TRT were poorly tolerated in the first North American cooperative group trial testing this regimen for locally advanced esophageal cancer as treatment-related mortality approached 10%. Single-institution phase-II cetuximab-based combined modality trials have yielded encouraging results in preliminary analyses. The SWOG GI Committee endorses enrollment to open clinical trials to clarify the therapeutic ratio of cetuximab-based combined modality approaches for esophageal cancer.
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