Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344356
Other study ID # 08-046
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2008
Est. completion date May 2018

Study information

Verified date March 2020
Source Mercy Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.


Description:

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

- Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection

- Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)

- Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient age > 18 years

- Zubrod performance status of 0-3

- Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma

- Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma

- Signed study-specific consent form

Exclusion Criteria:

- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females

- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Study Design


Intervention

Radiation:
stereotactic body radiotherapy
14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
Stereotactic body radiotherapy
8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)

Locations

Country Name City State
United States St. John's Mercy Medical Center Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Local Control Rate Complete or partial tumor response or stable disease 5 years
Primary Local Recurrence Instances of progressive disease 5 years
Primary Complication Rate Number of participants with any adverse event 5 years
Secondary Overall Survival Number of participants who are alive 5 years following treatment. 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05979961 - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT06055816 - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Phase 2
Recruiting NCT05547971 - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting NCT05020925 - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 1/Phase 2
Not yet recruiting NCT04547088 - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Not yet recruiting NCT04548271 - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02795169 - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02801487 - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02569788 - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT02237924 - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02044562 - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients N/A
Terminated NCT01694576 - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation Phase 2
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01271439 - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma Phase 2
Completed NCT00535795 - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA Phase 3
Completed NCT00379262 - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma Phase 3
Completed NCT03398980 - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy N/A
Completed NCT01309633 - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC) Phase 2