Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002654
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2019-05
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 plus cisplatin with radiation therapy alone in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with advanced head and neck cancer
Detailed Description:
OBJECTIVES I Assess the time to treatment failure local and regional in patients with moderately advanced and advanced squamous cell carcinoma of the head and neck no distant metastases when treated with hyperfractionated radiotherapy with vs without 2 courses of simultaneously administered cisplatin II Assess the time to distant metastatic relapse overall survival and toxicity in patients receiving these treatments III Evaluate whether the potential tumor-doubling time is an indicator for risk of treatment failure in patients receiving these treatments
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy followed as indicated by Surgery Hyperfractionated external-beam tumor irradiation using photon energies of 4-6 MV or electrons of 6-12 MV interstitial brachytherapy boost to lesions of the oral cavity allowed plus Cisplatin CDDP NSC-119875 followed in patients with persistent disease at the discretion of the surgeon by resection of primary tumor or involved nodes Arm II Hyperfractionated radiotherapy followed by Surgery Tumor irradiation as in Arm I followed by resection as in Arm I
PROJECTED ACCRUAL At least 400 patients will be accrued over 5 years Interim analyses to allow for early stopping will be carried out after entry of 50 and 100 patients
OUTLINE Randomized study Arm I Radiotherapy plus Single-Agent Chemotherapy followed as indicated by Surgery Hyperfractionated external-beam tumor irradiation using photon energies of 4-6 MV or electrons of 6-12 MV interstitial brachytherapy boost to lesions of the oral cavity allowed plus Cisplatin CDDP NSC-119875 followed in patients with persistent disease at the discretion of the surgeon by resection of primary tumor or involved nodes Arm II Hyperfractionated radiotherapy followed by Surgery Tumor irradiation as in Arm I followed by resection as in Arm I
PROJECTED ACCRUAL At least 400 patients will be accrued over 5 years Interim analyses to allow for early stopping will be carried out after entry of 50 and 100 patients
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 |
|---|---|---|---|
| CDR0000064188 | None | None | None |
| SWS-SAKK-1094 | None | None | None |
| EU-94039 | None | None | None |