Clinical trial · Interventional
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
NCT00608751CI-TRIAL-00010408IMRTterminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual and software issues
Summary
Brief summary (as posted)
Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT
- description
- External beam radiation with 6 MV photons will be delivered in 200 cGy daily fractions, 35 fractions over 7 weeks for a total dose of 7000 cGy.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
- timeFrame
- 7 weeks
- description
- Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.
Secondary outcomes (4)
- measure
- Measure additional time required by physician and ancillary staff for the process of adaptive IMRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 * Karnofsky Performance Status of \>= 60 * New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.) * All stages with measurable gross disease (\>= 1.0 cm) by CT imaging * Pathologic confirmation of squamous cell carcinoma by biopsy or cytology * Signed study-specific consent form * Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist) Exclusion Criteria * Age \< 18 * Karnofsky Performance Status \< 60 * Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes) * Prior radiation therapy to the head-and-neck region
References
Publications (0)
Data not yet available
No reference posted for this study.