Research: Head & Neck

Active Clinical Trials (September 5, 2003)

McNeil:A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine Hydrochloride 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects with Radiation-Induced Oral Mucositis (Protocol 00-107)

Inclusion/Exclusion: malignancy of oral cavity, oropharynx, and/or nasopharynx; scheduled to receive > 5500 cGy (SFX or HFX) w/wo concomitant chemo

Details: randomization in 2:2:1 ratio to benzydamine oral rinse, vehicle oral rinse, or standard of care; subjects assigned to oral rinses must begin prior to first RT and continue to rinse 4-8x/day until 2 wks post-RT; blinded oral evaluations 3x/week, food intake and quality of life questionnaires, and subject diaries to be completed; subjects provided with mouth care supplies, 3 cans Boost per day, $20 per study visit (3x/wk), and travel expenses

RTOG H-0129: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

Inclusion/Exclusion: squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx; selected Stage III or IV disease (T2, N2-3, M0 orT3-4, any N, M0); PS 0-1; verified bone marrow function and creatinine clearance

Details: randomization to either SFX (70 Gy/35 fx) plus cisplatin 100 mg/m2 on Days 1, 22, & 43 OR AFX-CB (72 Gy/42 fx) plus cisplatin 100 mg/m2 on Days 1 & 22

RTOG 0214: A Phase III Comparison of Prophylactic Cranial Irradiation versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer

Inclusion/Exclusion: Stage IIIA or IIIB NSCLC; completed all planned definitive locoregional/systemic therapy with CR, PR, or stable disease; enrollment within 16 wks of completing previous therapy, with all toxicities resolved to < Grade 2; MRI or CT head showing no suspicion for CNS metastases within 6 wks of entry; no evidence of distant metastatic disease; no prior cranial irradiation

Details: randomization to PCI (2 Gy/fx, 15 daily fx, total 30 Gy) or observation; brain MRI or CT at 6, 12, 24, &36 mo and yearly thereafter; Mini Mental Status Exam, Neurocognitive Evaluation Summary, Activities of Daily Living Scale at 3, 6, 12, 18, 24, 30, & 36 mo and yearly thereafter

CALGB 39904: Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients with Pulmonary Dysfunction: A Phase I Study

Inclusion/Exclusion: histologically or cytologically documented NSCLC; measurable disease; solitary T1N0 or T2N0 (< 4 cm) lesion; poor surgical risk due to pulmonary dysfunction or high-risk status; PS 0-2

Details: standard fractionation; dose intensity escalation, total dose 70.0 Gy in 29 fx (Cohort 1) decreasing to 17 fx (Cohort 5); treatment plans must be reviewed by QARC prior to initiating therapy

MedImmune: The Use of Amifostine for the Prevention of Acute and Late Toxicity of Altered Fraction Radiotherapy with Chemotherapy for Locally Advanced Head and Neck Cancer

Inclusion/Exclusion: histologically documented SCC of the head or neck; Stage III or IV disease; PS = 0-1; adequate bone marrow function and creatinine clearance; no evidence of distance metastases; no prior chemo or RT to H&N

Details:

(a) RT, 81.6 Gy in 68 fx (1.2 Gy/fx), using b.i.d. fractionation over 7 weeks;

(b) cisplatinum 20 mg /m2 on Day 1 and weekly during RT;

(c) amifostine 500 mg SQ on days of RT, 30-60 min before 1st daily fx;

(d) Performance Status Scale for Head and Neck Cancer (PSS-HN), Head and Neck Radiotherapy Questionnaire (HNRQ), Spitzer Quality of Life Index (SQLI), and xerostomia assessment prestudy, at end of RT, at 3 mo, at 12 mo, and yearly for years 2-5

Other Trials ...

In addition the Department of Radiation Oncology participates in a far greater number clinical trials than those which we actually sponsor. These include studies sponsored through Hematology/Oncology, Pediatrics, and Obstetrics and Gynocology which contain an Radiation Therapy component.

Other cancer related Cancer Clinical Trials at Upstate