Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057785
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2003-04-07
Brief Title:
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study Of Intensity Modulated Radiation Therapy IMRT - Chemotherapy For Nasopharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Giving radiation therapy in different ways may cause less damage to normal tissue prevent or lessen mouth dryness and may help patients live more comfortably Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer
PURPOSE Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer
Detailed Description:
OBJECTIVES
Determine the transportability of IMRT to a multi-institutional setting
Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy IMRT with or without chemotherapy
Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens
Determine the rate of local-regional control distant metastasis and disease-free and overall survival of patients treated with these regimens
Determine the acute and late toxicity of these regimens in these patients
Determine chemotherapy compliance in patients treated with these regimens
OUTLINE Patients undergo daily intensity-modulated radiotherapy IMRT 5 days a week for approximately 65 weeks total of 33 fractions in the absence of disease progression or unacceptable toxicity
Patients with stage T2b or greater andor node-positive disease receive cisplatin IV over 20-30 minutes on days 1 22 and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71 99 and 127
Quality of life is assessed through saliva measurement at baseline and then at 3 6 and 12 months after IMRT
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 64 patients will be accrued for this study within 36-40 months
Determine the transportability of IMRT to a multi-institutional setting
Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy IMRT with or without chemotherapy
Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens
Determine the rate of local-regional control distant metastasis and disease-free and overall survival of patients treated with these regimens
Determine the acute and late toxicity of these regimens in these patients
Determine chemotherapy compliance in patients treated with these regimens
OUTLINE Patients undergo daily intensity-modulated radiotherapy IMRT 5 days a week for approximately 65 weeks total of 33 fractions in the absence of disease progression or unacceptable toxicity
Patients with stage T2b or greater andor node-positive disease receive cisplatin IV over 20-30 minutes on days 1 22 and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71 99 and 127
Quality of life is assessed through saliva measurement at baseline and then at 3 6 and 12 months after IMRT
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 64 patients will be accrued for this study within 36-40 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000269314 | None | None | None |