Clinical trial · Interventional
Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity
Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage III Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage IVA Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage IVB Verrucous Carcinoma of the Oral Cavity | Oral Cavity Verrucous Carcinoma | CURATED_BROADER | 0.78 |
| Tongue Cancer | Malignant Tongue Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypofractionated IMRT, surgery)
- description
- Patients undergo hypofractionated IMRT every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment.
- interventionNames
- Radiation: hypofractionated radiation therapy
- Radiation: intensity-modulated radiation therapy
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Locoregional control
- timeFrame
- 2 years
- description
- Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is willing to sign study specific informed consent * Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma) * Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head \& neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology * Patient is deemed to be a surgical candidate by ENT * Karnofsky performance status (KPS) 0-2 * For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy * Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (CD4) count is \> 499/cu mm and their viral load is \< 50 copies/ml; use of highly active antiretroviral therapy (HAART) is allowed * Patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years Exclusion Criteria: * Metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (PET)/CT or biopsy * KPS 3 or worse * Gross disease in the retrostyloid (high level II) or retropharyngeal lymph node regions by CT or PET/CT * Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy * Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin * Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma * Women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patient is deemed to not be a surgical candidate by ENT
References
Publications (0)
Data not yet available