Upstate Active Clinical Trials Seeking Participants
Study title
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Recieving Cisplatan and Etopside.
IRB number
77
What is the purpose of the study?
To compare the effects, good and/or bad, of three different ways to give radiation therapy. Two of the ways are experimental, while one of them is standard. The two experimental ways of giving the radiation are (1) once a day with a high dose radiation for 7 weeks; or (2) once a day for 16 days of treatment (about 3 weeks), followed by twice a day for the remaining 9 days of treatment (about 2 weeks), for a total of 5 weeks. The standard way of giving radiation therapy is to give it twice a day for 3 weeks. All study participants will receive Cisplatin and Etoposide, which are the standard chemotherapy drugs for this type of cancer.
Who is eligible?
Histology or cytologically documented small cell lung cancer of limited stage.
Measurable or non-measurable disease.
No prior chemotherapy for SCLC or thoracic radiotherapy for any indication.
Patients with complete surgical resection of disease are not eligable.
Participants must meet minimal study criteria for baseline blood values.
Age greater than 18 years.
ECOG performance status of 0-2.
Non-pregnant and non-nursing.
What is involved if I participate?
- How long is the study?
Participants in this study will receive four cycles of chemotherapy over a period of approximetely 12 weeks. Beginning the same day as their first cycle of chemotherapy, all participants will also receive radiation therapy for a period of 5-7 weeks, depending on the treatment group to which they are assigned. After treatment is completed, participants will return for follow-up every 3 months during the first year, every 6 months during the second year, and annually thereafter. It is anticipated that it will take 4.5 years to enroll the necessary number of subjects in this study. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
PRE-TREATMENT Complete medical history. Standard blood tests (CBC & chemistries) Pulmonary function testing. Pregnancy test for women of child bearing potential. Spiral CT scans of the chest and abdomen. Bone Scan & PET scans. MRI (or CT) of the brain. TREATMENT & FOLLOW-UP. Radiation therapy once or twice daily, Monday-Friday, for a total of 5-7 weeks (depending on study treatment group to which each participant is assigned). Chemotherapy every 21 days for 4 cycles, for a total of 12 weeks: Day 1 - Cisplatin given over 60 minutes. Days 1, 2, & 3 - Etoposide given over 60 minutes. CBC on Days 1 & 8 of each cycle of chemotherapy. blood chemistries on Day 1 of each chemotherapy. physical exam and toxicity assessment on Day 1 of each chemotherapy. prophylactic cranial irradiation (PCI) will be offered to all patients with a complete or near complete response following treatment. spiral CT scan of the chest after Cycles 2 & 4 of chemotherapy and at each scheduled follow-up visit. MRI (or CT) of the brain after Cycle 4 of chemotherapy (prior to initiating PCI). pulmonary function testing 6 and 12 mo from the start of treatment. follow-up physical exams every 3 mo year 1, every 6 mo year 2, then yearly.
Who is the doctor administering the study?
Jeffrey A. 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?
April 2008 to ongoing
Who can I contact for more information?
- Name: Dena Martin
- Phone: 315-464-5262
- Email: martind@upstate.edu
- Fax: 315-464-5943
Other information:
Optional Study Components (for those subjects who choose to participate).
Studies on Blood: Three tubes of blood will be collected at four different time points (prior to treatment, Day 21, at first follow-up after completion, and at any time at which the subject's disease is found to have recurred).
Quality of Life: Subjects will fill out several questionaires regarding their physical symptoms, functioning, mood, and social life. These questionnaires will take about 25 minutes to complete on each occasion, and subjects will be asked to fill them out prior to treatment and again at weeks, 3, 5, 7, 12, 26, and 52 (a total of seven times). In addition, they will be asked a couple of questions about any difficulty they have swallowing every week while they recieve radiation therapy.
If you are interested in this trial, please contact the study coordinator or investigator noted above.
