Clinical trial · Interventional
Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC
A Phase I Dose Escalation Trial: Concurrent Intensity-Modulated Radiotherapy (IMRT) and Chemotherapy With Molecular Image-Guided Adaptive Radiation Therapy (IGART) for Advanced Head and Neck Squamous Cell Carcinomas (HNSCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated. The data analysis was futile with only 3 accruals. PI opted to terminate with IRB and withdraw FDA IND.
Summary
Brief summary (as posted)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Gland Squamous Cell Carcinoma | Salivary Gland Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage III Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Other | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| image-guided adaptive radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| positron emission tomography/computed tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: intensity-modulated radiation therapy
- Drug: cisplatin
- Radiation: image-guided adaptive radiation therapy
- Other: 3'-deoxy-3'-[18F]fluorothymidine
- Procedure: positron emission tomography/computed tomography
- Radiation: fludeoxyglucose F 18
Primary outcomes (1)
- measure
- Feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer
- timeFrame
- 6 weeks
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease * Locally advanced HN SCC, stages III, IV, and bulky (\> 27 cm\^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm\^3 volume base on CT scan * 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 * Candidate for chemotherapy * Zubrod performance score of 0 or 1 * Absolute granulocyte count (AGC) \>= 2000 cells/mm\^3 * Platelet count \>= 100,000 cells/mm\^3 * Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study * Serum creatinine =\< 1.5 mg/dl or measured or calculated creatinine clearance \>= 50 ml/min * Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential Exclusion Criteria: * Prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years * Prior cancer treatment for this cancer, including gross total tumor excision * Prior radiation treatment to the HN region * Patients with known syndromes that alter radiosensitivity * Any medical contraindications for chemotherapy * Pregnant or lactating women * Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter
References
Publications (0)
Data not yet available