Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095875
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2004-11-09
Brief Title:
Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer Paradigm Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase III Comparing Sequential Therapy With TPFChemoradiation ST To Cisplatinum-Based Chemoradiotherapy PARADIGM TRIAL
Status:
COMPLETED
Status Verified Date:
2013-10
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 Drugs used in chemotherapy such as docetaxel cisplatin fluorouracil and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel cisplatin and fluorouracil followed by radiotherapy and carboplatin or docetaxel vs radiotherapy and cisplatin only
Secondary
Compare 2-year progression-free status in patients treated with these regimens
Compare 5-year survival of patients treated with these regimens
Compare 3- and 5-year progression-free survival of patients treated with these regimens
Compare the complete response rate in patients treated with these regimens
Compare tumor site-specific survival in patients treated with these regimens
Compare functional organ preservation in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Correlate tissue and germline markers with response localregional control and the development of distant metastases in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction chemotherapy comprising docetaxel cisplatin and fluorouracil Treatment repeats every 21 days for 3 courses Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily 5 days a week for 7 weeks Patients with a partial response at the primary site ie positive biopsy stable disease or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily 5 days a week for 6 weeks
Arm II Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily 5 days a week for 6 weeks
Quality of life is assessed at baseline and then at 3 12 and 24 months
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 330 patients will be accrued for this study
Primary
Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel cisplatin and fluorouracil followed by radiotherapy and carboplatin or docetaxel vs radiotherapy and cisplatin only
Secondary
Compare 2-year progression-free status in patients treated with these regimens
Compare 5-year survival of patients treated with these regimens
Compare 3- and 5-year progression-free survival of patients treated with these regimens
Compare the complete response rate in patients treated with these regimens
Compare tumor site-specific survival in patients treated with these regimens
Compare functional organ preservation in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Correlate tissue and germline markers with response localregional control and the development of distant metastases in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction chemotherapy comprising docetaxel cisplatin and fluorouracil Treatment repeats every 21 days for 3 courses Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily 5 days a week for 7 weeks Patients with a partial response at the primary site ie positive biopsy stable disease or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily 5 days a week for 6 weeks
Arm II Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily 5 days a week for 6 weeks
Quality of life is assessed at baseline and then at 3 12 and 24 months
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 330 patients 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 |
|---|---|---|---|
| CDR0000393548 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |