Prospective Registration of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02546895
• Other study ID #: 2015-06-132
• Status: Recruiting
• Start date: September 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Samsung Medical Center
• Contact: Han-Sin Jeong, M.D. Ph.D.
• Phone: 82-2-3410-0291
• Email: hansin.jeong[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual incidence of Head and neck cancers is more than 650,000 the patients each year. Head and neck cancers are associated with smoking, alcohol consumption, human papilloma virus (type 16 and 18) and previous exposure to radiation.

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.

Description:

Review of medical records Medical records of enrolled patients will be reviewed to evaluate clinical characteristics, treatment-related adverse events, time to progression and overall survival.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults over 19 years-old

• 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.

Exclusion criteria:

• Patients who do not meet the requirements of inclusion criteria

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• chart review
The patient charts will be reviewed to determine pretreatment characteristics, treatment-related adverse events, time to progression and overall survival. 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

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. — View Citation

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. Erratum In: Lancet Oncol. 2010 Jan;11(1):14. — View Citation

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. — View Citation

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

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. Erratum In: J Clin Oncol. 2006 Feb 20;24(6):1015. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Revised RECIST guideline	3 years
Secondary	Identification of biomarkers of clinical significance (prognostic)	Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc)	5 years
Secondary	Number of participants with treatment-related morbidity	CTCAE protocol	5 years
Secondary	Number of participants with treatment response	Number of participants with treatment response	5 years
Secondary	Overall survival	Revised RECIST guideline	5 years
Secondary	Scores of distress questionnaire	QLQ HN43	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
Secondary	Scores of support survey	QLQ HN43	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
Secondary	Quality of life score	QLQ HN43	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