Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. We aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection

NCT02918955

Head and Neck Neoplasms

COMPLETED PHASE3

Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

NCT04284540

Head and Neck Squamous Cell Carcinoma (HNSCC)

COMPLETED NA

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

NCT02388932

Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma +25 more

TERMINATED NA

Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

NCT00891904

Head and Neck Cancer

TERMINATED NA

Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

NCT02158234

Squamous Cell Carcinoma of the Head and Neck

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.

Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.

Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.

Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Squamous Cell Carcinoma of the Head and Neck

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

unilateral radiation therapy

definitive external beam radiation in the ipsilateral neck.

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

definitive external beam radiation in the ipsilateral neck.

definitive external beam radiation in the ipsilateral neck

Intervention Type RADIATION

definitive external beam radiation in the ipsilateral neck

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation therapy

definitive external beam radiation in the ipsilateral neck.

Intervention Type RADIATION

definitive external beam radiation in the ipsilateral neck

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion \>1 cm from the midline.
* Patient has no clinical or radiologic evidence of contralateral neck node metastases.
* No evidence of distant metastasis.
* No previous history of radiation therapy or chemotherapy
* performance status 0-2
* Age \>= 18
* Signed informed consent
* Patients must be accessible for treatment and follow-up

Exclusion Criteria

* HIV positive patients
* Pregnancy or any patients not practicing contraception
* Active tobacco or alcohol addiction (as assessed by medical caregiver)
* Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
* Concomitant use of any trial anticancer therapeutic within 30 days of entry
* Uncontrolled hypertension
* Known hypersensitivity to mammalian cell-derived products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No