Active Clinical Trials (January, 2005)

Head & Neck

RTOG 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 or T3-4, 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

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:

• RT, 81.6 Gy in 68 fx (1.2 Gy/fx), using b.i.d. fractionation over 7 weeks;
• cisplatinum 20 mg /m 2 on Day 1 and weekly during RT;
• amifostine 500 mg SQ on days of RT, 30-60 min before 1 st daily fx;
• 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

Lung

RTOG 0212 (CALGB 30305):  A Phase II/III Randomized Trial of Two Doses (Phase III - Standard vs. High) and Two High Dose Schedules (Phase II - Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer

Inclusion/Exclusion: limited disease SCLC who have achieved a CR to induction chemo (+/- RT) > 1 week prior to study entry; PS 0-1; normal brain CT or MRI within one month of study entry

Details: at baseline, 6 mo, 12 mo, and yearly thereafter, all subjects undergo QOL and neuropsychological testing (test administrator certified by study chair);

Arm I - 2.5 Gy once daily, 10 fractions, total dose 25 Gy (50% of subjects)

Arm II - 2.0 Gy once daily, 18 fractions, total dose 36 Gy (25% of subjects)

Arm III - 1.5 Gy twice daily, 24 fractions, total dose 36 Gy (25% of subjects)

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

RTOG 0241 (CALGB 30202): Phase I Study of Irinotecan and Cisplatin in Combination with Twice Daily Thoracic Radiotherapy (45Gy) or Once Daily Thoracis Radiotherapy (70 Gy) for Patients with Limited Stage Small Cell Lung Cancer

Inclusion/Exclusion:   limited stage SCLC, clinical stage I-IIIB, confined to one hemithorax, excluding T4 tumor based on malignant pleural effusion and N3 disease based on contralateral involvement; PS = 0-1; no prior chemo, radiation, or biotherapy; pretreatment FEV1 > 1.0 L/sec; standard lab value requirements; no pre-existing > grade 2 peripheral neuropathy; patients with known Gilberts disease are excluded; patients receiving St. John's wort or enzyme-inducing anti-convulsant drugs on a regular basis for > 2 weeks are ineligible

Details:   a randomized dose escalation study in which patients are assigned in a sequential fashion, alternating between treatment sequences; treatment will begin with Sequence A, Level 1 (irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT 1.5 Gy bid), and after enrollment of 6 patients will progress to Sequence B, Level 1 (irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT 2.0 Gy once daily), escalating to Level 2 (irinotecan 50 mg/m2) and Level 3 (irinotecan 60 mg/m2) until the MTD in both treatment sequences is reached; in both sequences, post-RT chemo consists of irinotecan 60 mg/m2 and cisplatin 60 mg/m2 (3 cycles in Sequence 1, 2 cycles in Sequence 2) prior to restaging and possible PCI for those patients achieving a CR or those with PR who desire to receive it

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

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 Clinical Trials at Upstate