Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer
This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Purpose:
- The incremental staging information by using 18F-FDG PET
- The impact of the PET results on the patients' subsequent therapy planning
- To compare treatment response using RECIST criteria and FDG PET results.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Background: Esophageal cancer is one of the leading malignancies in Taiwan. Accuracy tumor staging can direct to appropriate therapy planning and provide prognostic implications. Positron emission tomography (PET) with [18F]-fluoro-2-deoxy-D-glucose (FDG) has been shown to have better N staging and prognostic stratification abilities than conventional imaging modalities, such as endoscopic ultrasonography (EUS) and CT.
Purpose: This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Method: Patients with pathological proven esophageal cancer, age 20-90 year-old, will be included in this study. Each patient will receive a baseline PET study. For those patients who received pre-operative CCRT, another PET will be performed 1-4 weeks after completion of CCRT.
Primary outcome: 1. The incremental staging information by using 18F-FDG PET 2. The impact of the PET results on the patients' subsequent therapy planning 3. To compare treatment response using RECIST criteria and FDG PET results.
Secondary outcome: To correlate the PET response rate and the patients' disease free survival and overall survival.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Taipei, Taiwan, 100
- Rekrutierung
- National Taiwan University Hospital
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Kontakt:
- Yen Ruoh Fang, M.D., Ph.D.
- Telefonnummer: 65581 886-2-23123456
- E-Mail: rfyen@ntu.edu.tw
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Hauptermittler:
- Yen Ruoh Fang, M.D., Ph.D.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age：20-90 years old
- Histological proved esophageal cancer
- ECOG performance status 0-2
- written informed consent signed
Exclusion Criteria:
- prior chemotherapy or treatment for other systemic anti-cancer agent(s)
- pregnant or intend to be pregnant
- other malignancies known
- other concurrent cancer treatment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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esophageal cancer, 18F-FDG PET
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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The effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Zeitfenster: 2 hours
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2 hours
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Yen Ruoh Fang, M.D.,Ph.D., National Taiwan University Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Yen TJ, Chung CS, Wu YW, Yen RF, Cheng MF, Lee JM, Hsu CH, Chang YL, Wang HP. Comparative study between endoscopic ultrasonography and positron emission tomography-computed tomography in staging patients with esophageal squamous cell carcinoma. Dis Esophagus. 2012 Jan;25(1):40-7. doi: 10.1111/j.1442-2050.2011.01204.x. Epub 2011 May 19.
- Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med. 2003 Dec 4;349(23):2241-52. doi: 10.1056/NEJMra035010. No abstract available.
- Ng T, Vezeridis MP. Advances in the surgical treatment of esophageal cancer. J Surg Oncol. 2010 Jun 15;101(8):725-9. doi: 10.1002/jso.21566.
- Chatterton BE, Ho Shon I, Baldey A, Lenzo N, Patrikeos A, Kelley B, Wong D, Ramshaw JE, Scott AM. Positron emission tomography changes management and prognostic stratification in patients with oesophageal cancer: results of a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2009 Mar;36(3):354-61. doi: 10.1007/s00259-008-0959-y. Epub 2008 Oct 18.
- Barber TW, Duong CP, Leong T, Bressel M, Drummond EG, Hicks RJ. 18F-FDG PET/CT has a high impact on patient management and provides powerful prognostic stratification in the primary staging of esophageal cancer: a prospective study with mature survival data. J Nucl Med. 2012 Jun;53(6):864-71. doi: 10.2967/jnumed.111.101568. Epub 2012 May 11.
- Yanagawa M, Tatsumi M, Miyata H, Morii E, Tomiyama N, Watabe T, Isohashi K, Kato H, Shimosegawa E, Yamasaki M, Mori M, Doki Y, Hatazawa J. Evaluation of response to neoadjuvant chemotherapy for esophageal cancer: PET response criteria in solid tumors versus response evaluation criteria in solid tumors. J Nucl Med. 2012 Jun;53(6):872-80. doi: 10.2967/jnumed.111.098699. Epub 2012 May 11.
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Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
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Mehr Informationen
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Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201207067MIC
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