Upstate Active Clinical Trials Seeking Participants
Study title
A RANDOMIZED PHASE III COMPARISON OF STANDARD-DOSE (60 Gy) VERSUS HIGH-DOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER
IRB number
75
What is the purpose of the study?
(a) To compare the overall survival of patients treated with high-dose versus standard-dose conformal radiation therapy in the setting of concurrent chemotherapy; (b) To compare the overall survival of patients treated with cetuximab versus without cetuximab in the setting of concurrent chemotherapy.
Who is eligible?
Pathologically proven Stage IIIA or IIIB non-small cell lung cancer. Patients must be considered unresectable or inoperable.
Measurable or evaluable disease.
Patients must meet minimal study criteria for baseline CBC, chemistries, and pulmunary function tests and have a performance status of 0 or 1.
Patients must NOT have N3 supraclavicular disease; greater than minimal pleural effusion or any pleural effusion which is exudative or cytogically positive; Pancoast tumors; involved contralateral hilar nodes; greater than 10% weight loss within the past month; prior invasive malignancy unless disease free for a minimum of 3 years; prior systematic chemotherapy for the study cancer; prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; severe active co-morbidities.
What is involved if I participate?
- How long is the study?
Participants will receive radiation therapy Mondat through Friday over a period of 6 to 7.5 weeks, depending on the treatment to which they are assigned. They will also receive concomitant chemotherapy one day each wekk while receiving radiation therapy, followed by additional chemotherapy either one day each week or one day every three weeks, again depending on the treatment to which they are assigned. Total treatment period will be between 85 and 113 days. Thereafter, participants will return for follow-up every 6 months during year 3 - 5, and annually thereafter. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Prior to Study: History and physical exam; diagnostic biopsy of tumor; CT scan of chest and upper abdomen; MRI scan of the brain (or CT if MRI cannot be performed); FDG-PET or PET-CT scan or bone scan; pulmonary function studies; routine blood tests; pregnancy test within 72 hr prior to treatment, if applicable. During Study and Follow-up Physical exam at 3 weeks, 6 weeks, 3 months, and then every 3 months for the first year, every 4 months for the second year, every 6 months for years 3-5, and yearly thereafter; routine blood tests; CT scan of chest/upper abdomen at competition of treatment, then every 6 months for 2 years, then annually. Optional Studies; Blood and urine specimen submissions at baseline, four weeks after start of treatment, and at first follow-up after treatment completion. Quality of life questionaires at baseline, end of treatment, 3 months, 12 months, and 2 years; swallowing diary weekly during treatment.
Who is the doctor administering the study?
Jeffrey Bogart, MD
Where will the study take place?
RT: University Hospital, Hill Rad Onc, Oswego County Rad Onc. Chemo: ROC, Hill Clinic (1000 E. Genesee, Oneida Clinic, Oswego Clinic
Over what time period is the study scheduled to run?
on going
Who can I contact for more information?
- Name: Dena Martin
- Phone: 315-464-5262
- Email: martind@upstate.edu
- Fax: 315-464-5943
If you are interested in this trial, please contact the study coordinator or investigator noted above.
