N/A
Completed N=16
Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer
Source: ClinicalTrials.gov NCT01843673 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Mar 2016
Primary outcomePrimary: Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies — -1.2; -0.8; -1.8; -1.5 mm — p=1.00
Summary
This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies |
-1.2; -0.8; -1.8; -1.5; -1.1; 1.3 | 1.00 |
| PRIMARY Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10% |
— | — |
| PRIMARY Greater Than or Equal to 5% Variation of Normal Tissue Toxicity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic confirmation of head and neck malignancy
- Patients who will be treated with definitive radiation therapy or concurrent chemoradiation therapy
- Gross tumor volume (GTV) must be visible on CT
- All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria
- Pregnant or nursing women may not participate; women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method
- Prior treatment with radiation therapy to the head and neck
- Serum creatinine > 1.5 and/or
- Blood urea nitrogen [BUN] > 25
- Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for this malignancy
- Patients with known syndromes expected to alter radiosensitivity (e.g. ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus [HIV]/acquired immunodeficiency deficiency syndrome [AIDS]) may not participate
Data sourced from ClinicalTrials.gov (NCT01843673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.