Phase II Trial Evaluating Elimination of Radiation Therapy (NCT00593840) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Trial Evaluating Elimination of Radiation Therapy
United States74 participantsStarted 2007-04-11
Plain-language summary
The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .
* Treated with surgical resection with one (or both) side(s) of the neck pathologically N0.
* Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:
* Close margin (\<= 0.5 cm)
* Positive margin
* Perineural invasion
* Lymphovascular space invasion
* Metastatic disease in more than one lymph node
* Metastatic disease in more than one lymph node group
* Extracapsular extension in any lymph node
* Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.
* Age \>= 18.
* Patients must sign study specific, Institutional Review Board (IRB)-approved consent form.
Exclusion Criteria:
* Previous head and neck cancer other than non melanoma skin cancer.
* Previous head and neck surgery.
* Female patients who are pregnant or nursing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a Recurrence in the Unirradiated Neck(s)