Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00188877
Other study ID # UHN REB 03-0158-C
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2003
Est. completion date June 2019

Study information

Verified date November 2019
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.

The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 2019
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation

- less than 70 yrs of age

- Stage T1-T4; N0-N3; M0

- KPS less than 70

- no prior RT to H&N or chemotherapy for H&N

- no other malignancy except non-melanomatous skin cancer

- no distant mets

- no contraindication to RT or chemotherapy

- adequate organ function

- informed consent

Exclusion Criteria

- Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
intensity modulated radiation therapy

Drug:
cisplatinium and fluorouracil - standard treatment


Locations

Country Name City State
Canada Princess Margaret Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques. q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter
Secondary -the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
Secondary -the nature and prevalence of acute and late side effects and their relationship to local dose.
Secondary -the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
Secondary -evaluation of failure with respect to the doses in the region of the failure
Secondary -quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma
See also
  Status Clinical Trial Phase
Completed NCT01256853 - Modified Vaccinia Ankara (MVA) Vaccine Study Phase 1
Not yet recruiting NCT00577057 - Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer N/A
Recruiting NCT02945878 - Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma N/A
Terminated NCT02874651 - ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy Phase 2
Not yet recruiting NCT05807880 - Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Completed NCT00342147 - Family Study of Head and Neck Cancers in Taiwan
Recruiting NCT02980315 - A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application Phase 1/Phase 2
Active, not recruiting NCT01735409 - Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT00630149 - Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy Phase 2
Completed NCT00565448 - Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents Phase 2
Active, not recruiting NCT03854838 - IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma. Phase 2
Completed NCT01797900 - The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Phase 2
Completed NCT00436800 - Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT00563927 - Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0) N/A
Not yet recruiting NCT04870905 - Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT02902432 - A Trial of Endostar in Patients With Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT02456506 - Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma. N/A
Completed NCT02444949 - A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma Phase 2
Terminated NCT00393224 - Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
Not yet recruiting NCT03093649 - Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma N/A