Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002476
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF VCRBLEOMTX5-FU vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2010-03
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer
Detailed Description:
OBJECTIVES I Determine whether the addition of methotrexate MTX or VBMF vincristinebleomycinmethotrexatefluorouracil to radiotherapy for advanced carcinoma of the head and neck with or without primary surgery influences locoregional control and prolongs survival II Determine whether an effect on locoregional control or survival is apparent when chemotherapy is given during or following radiotherapy and whether it is increased when chemotherapy is given at both times III Determine in a special randomization of patients with cancer of the oral cavity or oropharynx whether neck irradiation improves locoregional control and survival
OUTLINE Randomized study Patients without prior surgery are randomized 12 to Arms III-IV while those with prior surgery are randomized 11 between Arms I and II only Patients with tumors of the oral cavity or oropharynx may elect additional randomization between Arms V and VI and will receive irradiation of the primary according to the Manchester regimen Arm I Radiotherapy Irradiation of the primary andor lymph nodes according to 1 of 2 regimens Manchester 3-week schedule or SECOG 6-week schedule using megavoltage equipment Arm II Radiotherapy plus Concurrent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus Methotrexate MTX NSC-740 with Leucovorin calcium CF NSC-3590 or VBMF Vincristine VCR NSC-67574 Bleomycin BLEO NSC-125066 MTX Fluorouracil 5-FU NSC-19893 with CF Arm III Radiotherapy plus Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus MTX or VBMF with CF Arm IV Radiotherapy plus Concurrent and Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus MTX or VBMF with CF Arm V Radiotherapy Neck node irradiation using megavoltage equipment Arm VI Observation No nodal irradiation
PROJECTED ACCRUAL At least 1000 patients will be entered
OUTLINE Randomized study Patients without prior surgery are randomized 12 to Arms III-IV while those with prior surgery are randomized 11 between Arms I and II only Patients with tumors of the oral cavity or oropharynx may elect additional randomization between Arms V and VI and will receive irradiation of the primary according to the Manchester regimen Arm I Radiotherapy Irradiation of the primary andor lymph nodes according to 1 of 2 regimens Manchester 3-week schedule or SECOG 6-week schedule using megavoltage equipment Arm II Radiotherapy plus Concurrent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus Methotrexate MTX NSC-740 with Leucovorin calcium CF NSC-3590 or VBMF Vincristine VCR NSC-67574 Bleomycin BLEO NSC-125066 MTX Fluorouracil 5-FU NSC-19893 with CF Arm III Radiotherapy plus Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus MTX or VBMF with CF Arm IV Radiotherapy plus Concurrent and Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue Involved-field irradiation as in Arm I plus MTX or VBMF with CF Arm V Radiotherapy Neck node irradiation using megavoltage equipment Arm VI Observation No nodal irradiation
PROJECTED ACCRUAL At least 1000 patients will be entered
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 |
|---|---|---|---|
| UKHAN-1 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000076951 | REGISTRY | None | None |