Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002496
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Cancer of the Larynx
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
PHASE III TRIAL TO PRESERVE THE LARYNX INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY
Status:
COMPLETED
Status Verified Date:
2014-01
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 It is not yet known if chemotherapy plus radiation therapy is more effective than radiation therapy alone in treating patients with advanced cancer of the larynx
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced cancer of the larynx
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced cancer of the larynx
Detailed Description:
OBJECTIVES I Compare in a phase III setting overall and disease-free survival with preservation of laryngeal function in patients with stage IIIIV squamous cell carcinoma of the glottic and supraglottic larynx treated with cisplatinfluorouracil CDDP5-FU followed by radiotherapy vs concomitant radiotherapy plus CDDP vs radiotherapy alone II Compare the tumor response after completion of chemotherapy but prior to initiation of radiotherapy with that following completion of radiotherapy and concurrent chemotherapy III Compare the patterns of relapse local and regional recurrence and distant metastasis with these treatments IV Compare the incidence of second primary tumors in patients treated on these three regimens V Compare the acute and chronic adverse effects of these three regimens VI Compare the morbidity experienced with neck dissection andor laryngeal salvage surgery following treatment with these regimens VII Compare quality of life of patients with laryngeal preservation vs patients requiring salvage laryngectomies VIII Compare the quality of life of patients receiving radiotherapy alone vs those receiving chemotherapy as well
OUTLINE Randomized study Patients on any arm clinically staged N undergo neck dissection following completion of radiotherapy Arm I 2-Drug Combination Chemotherapy followed by Radiotherapy Cisplatin CDDP NSC-119875 Fluorouracil 5-FU NSC-19893 followed by regional irradiation using linear accelerators with photon energies of 125-6 MV electron energies of 8-17 MeV or Co60 Arm II Radiotherapy plus Single-Agent ChemotherapyRadiosensitization Regional irradiation using equipment as in Arm I plus CDDP Arm III Radiotherapy Regional irradiation using equipment as in Arm I
PROJECTED ACCRUAL 546 patients 182arm will be entered over approximately 3 years If any arm is clearly inferior in laryngectomy-free survival after 137 patients have completed 2 years of follow-up study that arm will be closed to further accrual A second interim analysis will be conducted after 410 patients have completed 2 years of follow-up
OUTLINE Randomized study Patients on any arm clinically staged N undergo neck dissection following completion of radiotherapy Arm I 2-Drug Combination Chemotherapy followed by Radiotherapy Cisplatin CDDP NSC-119875 Fluorouracil 5-FU NSC-19893 followed by regional irradiation using linear accelerators with photon energies of 125-6 MV electron energies of 8-17 MeV or Co60 Arm II Radiotherapy plus Single-Agent ChemotherapyRadiosensitization Regional irradiation using equipment as in Arm I plus CDDP Arm III Radiotherapy Regional irradiation using equipment as in Arm I
PROJECTED ACCRUAL 546 patients 182arm will be entered over approximately 3 years If any arm is clearly inferior in laryngectomy-free survival after 137 patients have completed 2 years of follow-up study that arm will be closed to further accrual A second interim analysis will be conducted after 410 patients have completed 2 years of follow-up
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 |
|---|---|---|---|
| SWOG-9201 | None | None | None |
| CDR0000077756 | None | None | None |
| EST-R9111 | None | None | None |