Clinical trial · Observational
Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
Prospective Observational Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer
NCT02003482CI-TRIAL-00032263completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT for Radiation Treatment Planning | Device | — | UNRESOLVED |
| Postop IMRT for head/neck cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Postop IMRT for Head/Neck cancer
- description
- CT for Radiation Treatment Planning
- interventionNames
- Radiation: Postop IMRT for head/neck cancer
- Device: CT for Radiation Treatment Planning
- label
- Chemo/IMRT for bulky Head/Neck cancer
- description
- CT for Radiation Treatment Planning
- interventionNames
- Radiation: Postop IMRT for head/neck cancer
- Device: CT for Radiation Treatment Planning
Primary outcomes (1)
- measure
- Volumetric/Dosimetric Changes During IMRT for bulky and postoperative head/neck patients
- timeFrame
- 7 weeks
- description
- To evaluate whether those patients undergoing standard intensity modulated radiation therapy (IMRT) for bulky and postoperative head and neck cancers demonstrate significant anatomic changes, causing dosimetric/volumetric changes during treatment which lead to under-dosing of tumor and/or over dosing of critical structures.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria: * If gross total resection is performed it must be completed within 7 weeks of registration * Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses) * Pretreatment evaluations required for eligibility include: * History and physical examination within four weeks prior to study entry * Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation * Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment * Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required * Patients must be ≥ 18 years of age. * Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment. * Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[hCG\], or in accordance with local regulations, whichever is more sensitive). * Patients must sign a study-specific informed consent form prior to registration. Exclusion Criteria: * Histology positive for melanoma. * Gross (visible or palpable) disease left after surgery. * Less than gross total resection or patients requiring staged surgery. * Prior head and neck radiotherapy. * Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
References
Publications (0)
Data not yet available
No reference posted for this study.