Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Phase II Randomized Study of Radiotherapy Versus Observation After Standard Platinum-Based Chemotherapy in Patients With Oligometastatic Stage IV Non-Small Cell Lung Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 18 and over | NCI | NCCTG-N0724 N0724, NCT00776100 |
Trial Description
Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer.
This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
Eligibility criteria include the following:
- At least 18 years old
- Received 2-6 courses of chemotherapy that included drugs such as cisplatin or carboplatin
- No previous treatment for this cancer other than chemotherapy with or without bevacizumab
- No previous radiation therapy to the cancer site
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will undergo observation for 6 weeks.
Patients in group two will undergo radiation therapy 5 days a week for 6 weeks.
After finishing treatment, patients will be evaluated every 3-6 months for up to 5 years.
Important:
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
North Central Cancer Treatment Group
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| Steven Schild, MD, Protocol chair | |
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| George Henning, MD, Protocol co-chair | |
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| Yolanda Garces, MD, Protocol co-chair | |
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| Alex Adjei, MD, PhD, Protocol co-chair | |
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| Philip Stella, MD, Protocol co-chair | |
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| Registry Information | ||
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| Official Title | A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated with Systemic Therapy plus Either Radiotherapy to all Sites of Gross Residual Disease or No Radiotherapy | |
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| Trial Start Date | 2008-10-31 | |
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| Trial Completion Date | 2010-09-21 | |
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| Registered in ClinicalTrials.gov | NCT00776100 | |
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| Date Submitted to PDQ | 2008-10-06 | |
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| Information Last Verified | 2010-07-16 | |
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| NCI Grant/Contract Number | CA25224 | |
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