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

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alovudine; Cisplatin; Dideoxynucleosides; Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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