Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2015-09-30
2025-12-31
Brief Summary
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So far, most of clinical and research data about head and neck cancers, such as the etiology, pathogenesis, prognosis factors and associated factors, treatment outcomes, are from Western countries. However, due to various environmental factors, for example race, genetics, geographical factors, general hygiene and health care system differences, the possibility of differences of disease characteristics between Western and Asian people should be considered.
For several decades, there have been many studies about treatment modalities (surgery, chemotherapy, and radiation therapy), complications and side effects for head and neck cancers in the West. Many institutions tried to improve the survival rate and resolve the toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However there has been little information about the characteristics of head and neck cancers, effectiveness of treatment (survival rate, recurrence, and complication rate), and prognosis, particularly in Korean as well as in Asian patients.
Therefore it is necessary to evaluate and analyze the features of head and neck cancers such as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site specific cohort (South Korea) separately. It could be helpful to improve the treatment outcomes of head and neck cancers overall, to design race or site specific treatments for head and neck cancers, and to develop management strategy common in Asia as well as the West.
The purpose of this study is
1. To establish the prospective tumor registry about patient's information, treatment-related morbidities, treatment outcomes and quality of life, in addition to the prospective collection of patient samples (blood and tumor tissues).
2. To establish the predictive model for treatment outcomes and treatment-related morbidities.
3. To develop the biomarkers as predictive and/or prognostic factors.
Detailed Description
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Behavioral : Questionnaires 3 times : Prior to the 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment Other Names : Surveys
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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chart review
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Behavioral: Questionnaires Completion of 3 questionnaires 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment. It may take about 30 minutes to complete the questionnaires each time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed as head and neck cancer histopathologically according to American Joint Committee on Cancer, Cancer staging manual, 7th edition at Samsung Medical Center:
* Comprise a part of head and neck
* Oral cavity
* Pharynx
* Larynx
* Hypopharynx
* Nasal cavity
* Paranasal sinus
* Nasopharynx
* Salivary gland
* Skin in the head and neck
* In case patients are diagnosed at other hospitals, it can be possible to register the tissue of cancer cell with Samsung medical center and confirm the diagnosis by pathologists of Samsung medical center.
* Histopathological type:
* Squamous cell carcinoma
* Malignant melanoma
* Sarcoma and other carcinomas are included.
* Metastasis of Unknown Origin (MUO) at head and neck is included.
* Patients who receive a proper treatment as scheduled.
* Informed consents: patients who understand the purpose of study and are capable of giving a written consent.
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Han-Sin Jeong
Professor
Principal Investigators
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Han-Sin Jeong, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
Se-Hoon Lee, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
Dongryul Oh, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
Chung-Hwan Baek, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
Young-Ik Son, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
Man Ki Chung, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center
Young Chan Ahn, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
Myung-Ju Ahn, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
Keunchil Park, M.D.Ph.D.
Role: STUDY_CHAIR
Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Leemans CR, Braakhuis BJ, Brakenhoff RH. The molecular biology of head and neck cancer. Nat Rev Cancer. 2011 Jan;11(1):9-22. doi: 10.1038/nrc2982. Epub 2010 Dec 16.
Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.
Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.
Seiwert TY, Salama JK, Vokes EE. The chemoradiation paradigm in head and neck cancer. Nat Clin Pract Oncol. 2007 Mar;4(3):156-71. doi: 10.1038/ncponc0750.
Seiwert TY, Salama JK, Vokes EE. The concurrent chemoradiation paradigm--general principles. Nat Clin Pract Oncol. 2007 Feb;4(2):86-100. doi: 10.1038/ncponc0714.
Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol. 2008 Jul 1;26(19):3128-37. doi: 10.1200/JCO.2007.12.7662. Epub 2008 May 12.
Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.
Hitt R, Lopez-Pousa A, Martinez-Trufero J, Escrig V, Carles J, Rizo A, Isla D, Vega ME, Marti JL, Lobo F, Pastor P, Valenti V, Belon J, Sanchez MA, Chaib C, Pallares C, Anton A, Cervantes A, Paz-Ares L, Cortes-Funes H. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005 Dec 1;23(34):8636-45. doi: 10.1200/JCO.2004.00.1990. Epub 2005 Nov 7.
Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10.
Hah, J. H. (2012). Personalized Treatment of Head and Neck Cancers and the Role of Head and Neck Surgeons. Korean Journal of Otorhinolaryngology-Head and Neck Surgery, 55(8), 471-475
Glisson BS, Murphy BA, Frenette G, Khuri FR, Forastiere AA. Phase II Trial of docetaxel and cisplatin combination chemotherapy in patients with squamous cell carcinoma of the head and neck. J Clin Oncol. 2002 Mar 15;20(6):1593-9. doi: 10.1200/JCO.2002.20.6.1593.
Kang D, Kim E, Choi N, Kim H, Cho J, Jeong HS. Pre-treatment quality of life in patients with salivary gland cancer in comparison with those of head and neck cancer patients. Qual Life Res. 2023 May;32(5):1493-1506. doi: 10.1007/s11136-022-03323-8. Epub 2022 Dec 13.
Other Identifiers
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2015-06-132
Identifier Type: -
Identifier Source: org_study_id