Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT01587820
Status:
TERMINATED
Last Update Posted:
2014-12-05
First Post:
2012-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-arterial Versus Intravenous Cisplatin, Combined With Radiation, for Oral Cavity and Oropharynx Cancer
Sponsor:
Southern Illinois University
Organization:
Study Overview
Official Title:
A Pilot/ Feasibility Study Comparing Response Rates of Intra-arterial and Intravenous Cisplatin Chemotherapy, Combined With Radiation, in Patients With Locally Advanced Carcinoma of the Oral Cavity and Oropharynx
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, open-label investigator initiated pilot/ feasibility study comparing the effectiveness of intra-arterial administration of cisplatin therapy to intravenous administration of cisplatin when each is combined with the radiation therapy found in standard care. Participants will be randomized to either intra-arterial or intravenous cisplatin chemotherapy. This study is designed to determine whether a large scale study is practical in the investigators clinical setting. Approximately 10 subjects will be enrolled over a 2 year period.
Detailed Description:
Head and neck malignancies represent a group of epithelial tumors that arise from the oral cavity, pharynx, and larynx and account for about 3 to 5% of all cancers in the United States. In 2010, an estimated 49,260 people (35,530 men and 13,730 women) will develop head and neck cancer, and an estimated 11,480 deaths (8,300 men and 3,180 women) will occur.
Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation therapy, and surgery. The choice of modality depends upon many factors such as the site and extent of the primary lesion, the likelihood of complete surgical resection, the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively treated either, by surgical excision or irradiation whereas more advanced disease (T3-T4) is treated with combined surgery and radiation or chemoradiation. The goal of concurrent chemotherapy with radiation is to increase locoregional control and prevent distant metastases.
A specific concomitant chemoradiation protocol for head and neck cancer known as RADPLAT employs the pharmacologic principles and techniques described above. Capitalizing on the cisplatin-neutralizing agent sodium thiosulfate and its pharmacokinetic properties, enormous concentrations of cisplatin can be infused directly into large head and neck tumors through a targeted IA approach. In a Phase I study, it was determined that cisplatin could be safely administered to patients with advanced and recurrent head and neck cancer at a dose intensity of 150mg/m2/week.
The patient must be considered a clinical candidate for either intra-arterial or intravenous administration of cisplatin to be eligible for the study. Once enrolled and registered on the study, the subject will be randomized to either intravenous or intra-arterial administered cisplatin. Subjects will be assigned in a 1:1 ratio of intra-arterial versus intravenous administration. All patients will receive concurrent radiation therapy. Standard institutional practice will be applied for dose reduction and treatment of radiation therapy related toxicities.
A combination of lateral opposing fields will be used for the treatment of the primary tumor site and upper neck when three dimensional CRT is used and is not applicable for IMRT. A single anterior A-P field can be used to treat the lower neck below the primary tumor/upper neck. When there are positive nodes in the lower neck, an additional posterior field may be necessary to deliver a supplemental dose to the positive nodes. All fields must be treated on each treatment session.
The investigators will measure feasibility of the study protocol through enrollment and screen failure data. The study will test the hypothesis that intra-arterial cisplatin is more effective for patient outcomes in overall survival, disease free survival, cancer specific survival, rate of local and regional control of cancer, site of recurrence, organ preservation rate, toxicity, and correlative specimen availability.
Three modalities of therapy have established roles in the treatment of carcinoma of the head and neck: chemotherapy, radiation therapy, and surgery. The choice of modality depends upon many factors such as the site and extent of the primary lesion, the likelihood of complete surgical resection, the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are effectively treated either, by surgical excision or irradiation whereas more advanced disease (T3-T4) is treated with combined surgery and radiation or chemoradiation. The goal of concurrent chemotherapy with radiation is to increase locoregional control and prevent distant metastases.
A specific concomitant chemoradiation protocol for head and neck cancer known as RADPLAT employs the pharmacologic principles and techniques described above. Capitalizing on the cisplatin-neutralizing agent sodium thiosulfate and its pharmacokinetic properties, enormous concentrations of cisplatin can be infused directly into large head and neck tumors through a targeted IA approach. In a Phase I study, it was determined that cisplatin could be safely administered to patients with advanced and recurrent head and neck cancer at a dose intensity of 150mg/m2/week.
The patient must be considered a clinical candidate for either intra-arterial or intravenous administration of cisplatin to be eligible for the study. Once enrolled and registered on the study, the subject will be randomized to either intravenous or intra-arterial administered cisplatin. Subjects will be assigned in a 1:1 ratio of intra-arterial versus intravenous administration. All patients will receive concurrent radiation therapy. Standard institutional practice will be applied for dose reduction and treatment of radiation therapy related toxicities.
A combination of lateral opposing fields will be used for the treatment of the primary tumor site and upper neck when three dimensional CRT is used and is not applicable for IMRT. A single anterior A-P field can be used to treat the lower neck below the primary tumor/upper neck. When there are positive nodes in the lower neck, an additional posterior field may be necessary to deliver a supplemental dose to the positive nodes. All fields must be treated on each treatment session.
The investigators will measure feasibility of the study protocol through enrollment and screen failure data. The study will test the hypothesis that intra-arterial cisplatin is more effective for patient outcomes in overall survival, disease free survival, cancer specific survival, rate of local and regional control of cancer, site of recurrence, organ preservation rate, toxicity, and correlative specimen availability.
Study Oversight
Has Oversight DMC:
True
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?: