An Early Phase 1 interventional study of Intra-arterial cisplatin and Intravenous cisplatin in Head and Neck Cancer, sponsored by Southern Illinois University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-05.
Sponsored by Southern Illinois University · Early Phase 1, Interventional, and Treatment
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 1 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Southern Illinois University is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
150 mg/m2 cisplatin given intra-arterially combined with sodium thiosulfate infusion given on days 1, 8, 15, for a total of 4 cycles, each cycle totaling 7 days and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
Drug: Intra-arterial cisplatin
100 mg/m2 cisplatin given intravenously once every 21 days (3 week cycle) for 3 cycles and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
Drug: Intravenous cisplatin
150 mg/m2 cisplatin given intra-arterially combined with sodium thiosulfate infusion given on days 1, 8, 15, for a total of 4 cycles, each cycle totaling 7 days and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
100 mg/m2 cisplatin given intravenously once every 21 days (3 week cycle) for 3 cycles and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
number of enrolled subjects
enrollment
Time frame: 2 years
patient survival
patient survival data including overall survival, disease free survival, and cancer specific survival
Time frame: 2 years
rate of patient morbidity
rate of local and regional control of cancer, including site of recurrence and organ preservation rate
Time frame: 2 years
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Southern Illinois University