Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

Stopped early · Phase 1

Conditions studied: Salivary Gland Squamous Cell Carcinoma, Stage II Salivary Gland Cancer, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Verrucous Carcinoma of the Oral Cavity

In brief

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer

Key facts

Study ID

NCT01283178

Run by

Virginia Commonwealth University

People needed

3

Starts

2011-07-01

Expected to finish

2016-09-01

Last updated by the study team

2016-10-31

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
• Locally advanced HN SCC, stages III, IV, and bulky (> 27 cm\^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm\^3 volume base on CT scan
• All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
• Candidate for chemotherapy
• Zubrod performance score of 0 or 1
• Absolute granulocyte count (AGC) >= 2000 cells/mm\^3
• Platelet count >= 100,000 cells/mm\^3
• Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study
• Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
• Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential

You may not qualify if…

• Prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
• Prior cancer treatment for this cancer, including gross total tumor excision
• Prior radiation treatment to the HN region
• Patients with known syndromes that alter radiosensitivity
• Any medical contraindications for chemotherapy
• Pregnant or lactating women
• Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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