Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014118
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2001-04-10
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use 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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx
Detailed Description:
OBJECTIVES
Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy
Determine the feasibility and toxicity of this regimen in these patients
Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen
Determine the disease-free survival and patterns of failure of patients treated with this regimen
Determine the objective tumor response rate complete and partial response in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin
Determine changes in quality of life of patients treated with this regimen
Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to disease site larynx vs oropharynx
Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22 Within 28 days after completion of induction therapy patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1 8 15 22 29 36 and 43 and radiotherapy once daily 5 times weekly for 7 weeks beginning on day 1
Within 6-8 weeks after completion of therapy patients who initially had bulky neck disease N3 or who have residual palpable lymphadenopathy undergo surgical neck dissection Patients with N1-N2 disease with complete response may also undergo neck dissection Patients with initial complete response who recur at the primary site undergo surgical salvage
Quality of life is assessed at baseline after induction therapy and at 3 12 and 24 months after completion of all therapy
Patients are followed at 6 weeks 3 months every 6-8 weeks for 1 year every 3 months for 1 year every 4 months for 1 year and then every 6 months for 5 years thereafter
PROJECTED ACCRUAL A total of 110 patients 55 per stratum will be accrued for this study
Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy
Determine the feasibility and toxicity of this regimen in these patients
Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen
Determine the disease-free survival and patterns of failure of patients treated with this regimen
Determine the objective tumor response rate complete and partial response in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin
Determine changes in quality of life of patients treated with this regimen
Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to disease site larynx vs oropharynx
Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22 Within 28 days after completion of induction therapy patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1 8 15 22 29 36 and 43 and radiotherapy once daily 5 times weekly for 7 weeks beginning on day 1
Within 6-8 weeks after completion of therapy patients who initially had bulky neck disease N3 or who have residual palpable lymphadenopathy undergo surgical neck dissection Patients with N1-N2 disease with complete response may also undergo neck dissection Patients with initial complete response who recur at the primary site undergo surgical salvage
Quality of life is assessed at baseline after induction therapy and at 3 12 and 24 months after completion of all therapy
Patients are followed at 6 weeks 3 months every 6-8 weeks for 1 year every 3 months for 1 year every 4 months for 1 year and then every 6 months for 5 years thereafter
PROJECTED ACCRUAL A total of 110 patients 55 per stratum 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 |
|---|---|---|---|
| ECOG-2399 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |