Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268372
Status:
TERMINATED
Last Update Posted:
2012-10-04
First Post:
2005-12-21
Brief Title:
S0427 Combination Chemotherapy RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin With and Without Docetaxel Cisplatin and 5-Fluorouracil Induction Chemotherapy in Patients With Advanced Oropharyngeal Squamous Cell Cancer
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SWOG eliminated its head and neck committee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel cisplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving combination chemotherapy together with radiation therapy may kill more tumor cells It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx
PURPOSE This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx
PURPOSE This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising docetaxel cisplatin and fluorouracil followed by radiotherapy and cisplatin versus radiotherapy and cisplatin only
Compare the progression-free survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life and functional status of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to primary cancer site base of tongue vs other nodal extent N0-1 vs N2-3 radiotherapy plan conventional 2-D or 3-D conformal radiotherapy vs intensity modulated radiotherapy Patients are randomized to 1 of 2 treatment arms
Arm I induction chemotherapy with or without salvage surgery followed by chemoradiotherapy
Induction chemotherapy with or without early salvage surgery Patients receive docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 1-3 courses Patients achieving complete or partial response at the primary site after course 1 receive 2 additional courses of therapy and then proceed to chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration Patients with stable disease or surgically resectable locoregional disease progression undergo early salvage surgery and then proceed to concurrent chemoradiotherapy within 70 days after surgery Patients with locoregional unresectable disease progression or patients who refused early salvage surgery proceed directly to concurrent chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration
Chemoradiotherapy Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes concurrently on days 1 22 and 43 in the absence of disease progression or unacceptable toxicity
NOTE Patients undergoing surgery before chemoradiotherapy receive cisplatin on days 1 and 22 only of a 6-week course of radiotherapy
Arm II chemoradiotherapy only Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes on days 1 22 and 43 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after completion of chemoradiotherapy and then at 12 months after randomization
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL Approximately 398 patients 199 per treatment arm will be accrued for this study
Primary
Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising docetaxel cisplatin and fluorouracil followed by radiotherapy and cisplatin versus radiotherapy and cisplatin only
Compare the progression-free survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life and functional status of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to primary cancer site base of tongue vs other nodal extent N0-1 vs N2-3 radiotherapy plan conventional 2-D or 3-D conformal radiotherapy vs intensity modulated radiotherapy Patients are randomized to 1 of 2 treatment arms
Arm I induction chemotherapy with or without salvage surgery followed by chemoradiotherapy
Induction chemotherapy with or without early salvage surgery Patients receive docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 1-3 courses Patients achieving complete or partial response at the primary site after course 1 receive 2 additional courses of therapy and then proceed to chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration Patients with stable disease or surgically resectable locoregional disease progression undergo early salvage surgery and then proceed to concurrent chemoradiotherapy within 70 days after surgery Patients with locoregional unresectable disease progression or patients who refused early salvage surgery proceed directly to concurrent chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration
Chemoradiotherapy Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes concurrently on days 1 22 and 43 in the absence of disease progression or unacceptable toxicity
NOTE Patients undergoing surgery before chemoradiotherapy receive cisplatin on days 1 and 22 only of a 6-week course of radiotherapy
Arm II chemoradiotherapy only Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes on days 1 22 and 43 in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after completion of chemoradiotherapy and then at 12 months after randomization
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL Approximately 398 patients 199 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0427 | OTHER | None | None |