Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002774
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2000-04-06
Brief Title:
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Randomized Phase 2 Trial of Tirapazamine and the Role of Tumor Hypoxia in Advanced Squamous Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
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:
PURPOSE Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy RT cisplatin 5-FU with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer SCCHN
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells
Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells
Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy
Detailed Description:
Subjects were stratified according to pO2 values high vs low and randomized to 1 of 2 treatment arms differing by the addition of tirapazamine to the therapeutic regimen Treatment consists of two 21-day cycles of induction chemotherapy followed by radiotherapy RT
Induction chemotherapy was cisplatin 100 mgm2 per day administered over 4 hours on Study Days 1 and 22 ie 1st day of both induction cycles with continuous infusion CI 5-FU at a dose of 1000 mgm2 per day for 120 hours per cycle starting on Study Days 1 and 22 ie days 1 to 5 of both induction cycles
Patients who achieve at least partial response proceeded to chemoradiotherapy CRT consisting of localized RT cisplatin IV 5-FU - tirapazamine Location of RT was based on whether the site had a CR or PR Radiotherapy began on day 43 week 1 and continued for 55 weeks Subjects with no response or progressive disease proceeded to salvage surgery
A total of 63 patients were accrued for this study over approximately 5 years 1 subject withdrew consent prior to treatment for personal reasons
Induction chemotherapy was cisplatin 100 mgm2 per day administered over 4 hours on Study Days 1 and 22 ie 1st day of both induction cycles with continuous infusion CI 5-FU at a dose of 1000 mgm2 per day for 120 hours per cycle starting on Study Days 1 and 22 ie days 1 to 5 of both induction cycles
Patients who achieve at least partial response proceeded to chemoradiotherapy CRT consisting of localized RT cisplatin IV 5-FU - tirapazamine Location of RT was based on whether the site had a CR or PR Radiotherapy began on day 43 week 1 and continued for 55 weeks Subjects with no response or progressive disease proceeded to salvage surgery
A total of 63 patients were accrued for this study over approximately 5 years 1 subject withdrew consent prior to treatment for personal reasons
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 |
|---|---|---|---|
| SQL 72951 | OTHER | Stanford IRB legacy identifier | None |
| CA67166 | OTHER_GRANT | None | None |
| NCI-T94-0119O | OTHER | None | None |
| CDR0000064752 | None | None | None |