EUCTR2016-000373-21-HU
Active, not recruiting
Phase 1
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with the IRX-2 Regimen in Patients with Newly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity
Conditionsewly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity.MedDRA version: 20.0Level: PTClassification code 10041857Term: Squamous cell carcinoma of the oral cavitySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsForceval
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly Diagnosed Stage II, III or IVA Squamous Cell Carcinoma of the Oral Cavity.
- Sponsor
- IRX Therapeutics, Inc.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pathologically confirmed diagnosis of Stage II, III or IVA squamous cell cancer of the oral cavity (excluding the lip). Staging must be done using AJCC Cancer Staging Manual Edition 7\.0\.
- •2\. Subjects: males or females at least 18 years of age at study entry.
- •3\. Disease is surgically resectable with a curative intent.
- •4\. Karnofsky Performance Status \= 70%.
- •5\. Haematological, Hepatic and Renal functions are adequate for surgical intervention.
- •6\. Females of child\-bearing potential must have negative urine/serum pregnancy test and agree to used a highly effective form of birth control.
- •7\. Subjects are able to give Informed Consent and adhere to the protocol treatment plan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Prior surgery, radiation or chemotherapy (excluding biopsy or any procedure required for supportive care).
- •2\. Tumour of the oropharynx.
- •3\. Tumour involvement likely to be associated with T4b cancer.
- •4\. Distant metastased (M1 disease).
- •5\. Diagnosis of another invasive cancer which is currently not in remission and has required treatment within the last 5 years.
- •6\. Known infection with hepatitis B, C or HIV.
- •7\. Use of any Investigational agent within 30 days of randomization.
- •8\. Symptomatic cardiopulmonary disease which are not clinical stable.
- •9\. Myocardial infarction within the last 3 months.
- •10\. Stroke or other cerebral vascular insufficiency within last 3 months.
Outcomes
Primary Outcomes
Not specified
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