Clinical trial · Interventional
A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
NCT00490282CI-TRIAL-00049194completedN/AResults postedClinicalTrials.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)
The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.
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 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive Radiotherapy | Radiation | — | UNRESOLVED |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Image-Guided Adaptive Radiotherapy
- description
- Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
- Radiation: Adaptive Radiotherapy
Primary outcomes (1)
- measure
- Dosimetric Comparisons With Adaptive Radiotherapy (ART) Planning to Intensity-modulated Radiation Therapy (IMRT) Planning
- timeFrame
- Baseline by IMRT plan and adaptive dosing by ART plan evaluated during a 6-7 week course of treatment
- description
- Comparison of mean dose in the Contralateral Parotid Gland and Ipsilateral Parotid Gland change between one adaptive replan (ART1) and two adaptive replans (ART2) planning relative to standard intensity-modulated radiation therapy (IMRT) planning. Dosimetric comparisons was performed using paired t-testing between plans, with patients serving as their own controls. The median trigger point for ART1 was the 16th treatment fraction. For ART2 patients, the median trigger points for the first and second replanning were the 11th and the 22nd fractions, respectively. Percent change in mean dose calculated for each group as 100% (mean post baseline (ART1 or ART2) dosage minus mean baseline IMRT dose for each parotid gland
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor. 2. Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion Criteria: 1. Patients who have undergone definitive resection of the primary tumor. 2. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer. 3. Prior radiation therapy to the head and neck region. 4. Patients unable or unwilling to give written, informed consent or to undergo MRI imaging. 5. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study 6. Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m2. 7. Patients who have had prior chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.