Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004234
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-01-28
Brief Title:
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth Pharynx or Larynx
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2020-04
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 at different times of the day may affect the chance of developing side effects such as mucositis
PURPOSE Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth pharynx or larynx who are receiving radiation therapy in either the morning or afternoon
PURPOSE Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth pharynx or larynx who are receiving radiation therapy in either the morning or afternoon
Detailed Description:
OBJECTIVES
Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity pharynx orohyponaso or larynx who will receive radiation treatment to a significant part of the oral andor oropharyngeal mucosa
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center intended smoking behavior during therapy smoking vs nonsmoking and planned total radiotherapy dose
Patients are randomized to receive radiotherapy once daily 5 days a week at one of two of the following times of the day
Arm I Patients receive radiotherapy between 8 and 10 AM local time
Arm II Patients receive radiotherapy between 4 and 6 PM local time Treatment continues for 5-8 weeks depending on planned total radiotherapy dose in the absence of unacceptable toxicity or disease progression
Toxicity is assessed at baseline at the first fraction of radiotherapy weekly during treatment weekly until mucositis has peaked and is improving and then every 2 weeks until mucositis has improved to less than grade 2
Quality of life is assessed at baseline weekly during treatment and until toxicity has peaked and is improving every 2 weeks until toxicity is less than grade 2 mucositis and then at each follow-up visit until week 24
Patients are followed at weeks 2-3 6-8 12 and 24 and then annually for 3 years
PROJECTED ACCRUAL A total of 216 patients 108 per treatment arm will be accrued for this study
Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity pharynx orohyponaso or larynx who will receive radiation treatment to a significant part of the oral andor oropharyngeal mucosa
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center intended smoking behavior during therapy smoking vs nonsmoking and planned total radiotherapy dose
Patients are randomized to receive radiotherapy once daily 5 days a week at one of two of the following times of the day
Arm I Patients receive radiotherapy between 8 and 10 AM local time
Arm II Patients receive radiotherapy between 4 and 6 PM local time Treatment continues for 5-8 weeks depending on planned total radiotherapy dose in the absence of unacceptable toxicity or disease progression
Toxicity is assessed at baseline at the first fraction of radiotherapy weekly during treatment weekly until mucositis has peaked and is improving and then every 2 weeks until mucositis has improved to less than grade 2
Quality of life is assessed at baseline weekly during treatment and until toxicity has peaked and is improving every 2 weeks until toxicity is less than grade 2 mucositis and then at each follow-up visit until week 24
Patients are followed at weeks 2-3 6-8 12 and 24 and then annually for 3 years
PROJECTED ACCRUAL A total of 216 patients 108 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000067478 | OTHER | PDQ | None |
| CAN-NCIC-HN3 | OTHER | None | None |