Neoplasms

All Conditions

Rare Diseases

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Addition to the cervical angio-MRI, of a sequence of 1H-SRM 3T (SUCCESS) centered on the lesion studied, performed according to the following parameters: PRESS asymmetric monovoxel "PROBE", TE 144 ms, TR 2500 ms, 768 or 1024 medium.

PRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages

1H-Spectroscopy MRI

Charlotte LUSSEY-LEPOUTRE, PhD

Malha BERRAH, MSc

Philippe HERMAN, Dr

Charlotte LUSSEY-LEPOUTRE, Dr

Laurence AMAR, PhD

Qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. We aim at assessing the added value of 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

Paragangliomas (PGL) are rare neuroendocrine tumors inherited in 40% of cases. SDHx genes (SDHA, SDHB, SDHC, SDHD), encoding the 4 subunits of the mitochondrial enzyme succinate dehydrogenase (SDH), are the most frequently involved.

Accumulation of succinate, the substrate for SDH, is a very specific biomarker for these mutations. Recently, we have demonstrated the feasability of detecting and quantifying succinate in tumors in vivo, by magnetic resonance spectroscopy (1H-SRM).

Patients carrying these mutations frequently develop cervical PGL for which the treatment of choice is external beam radiation therapy (EBR).

The objective of this project is to determine the feasibility of using 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas

Evolution of Succinate Accumulation Detected in Vivo by Spectroscopic Magnetic Resonance Imaging (1H-SRM) After External Beam Radiation Therapy in SDHx-mutated Patients With Cervical Paragangliomas

Individual participant data (IPD) that underlie results in publication could be shared.

Absence of succinate accumulation detected in vivo by 1H-SRM, in cervical PGLs with SDHx mutations, at 12 months after EBR, reviewed by 2 independant experts blinded to all other clinical and genetics data.

Absence of succinate accumulation detected in vivo by 1H-SRM, in cervical PGLs with SDHx mutations, at 3 months after EBR, reviewed by 2 independant experts blinded to all other clinical and genetics data.

Reference diagnostic for response assessed by MRI at 3 months and 12 months after EBR: 1/ Complete response : tumour disappearance ; 2/ Partial response : decrease by at least 30% of tumour volume and no clinical symptomatology worsening ; 3/ stable : stability of tumour size and no clinical symptomatology worsening; 4/ Progression : increase by at least 20% of tumour volume and/or clinical symptomatological worsening

PERCIST criteria (PET response criteria in solid tumors) assessed by PET/CT at 3 months and 12 months after EBR

Occurence of an event related to the disease during 12 months follow-up (metastatic evolution of the disease or death). Metastases diagnostic is assessed remotely by presence in chromaffin tissue (http://www.sfendocrino.org/article/599/recommandations)

Society for Endocrinology

Assistance Publique - Hôpitaux de Paris

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Skin and Connective Tissue Diseases

Nasopharyngeal Carcinoma

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Sarcoma

Chondrosarcoma

Chordoma

Angiofibroma

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Neoplasms, Connective and Soft Tissue

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Neoplasms

Mouth Diseases

Salivary Gland Diseases

Neoplasms, Connective Tissue

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Oral Cancer

Benign head and neck tumors will be treated with SBRT

Malignant Head and Neck Tumors will be treated with SBRT.

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)

Stereotactic body radiotherapy

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.

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.

Stereotactic Body Radiotherapy for Head and Neck Tumors

Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

Complete or partial tumor response or stable disease

Number of participants with any adverse event

Number of participants who are alive 5 years following treatment.

Mercy Research

Physician

Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0

Benign head and neck tumors will be treated with SBRT

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Benign Tumors

Malignant Head and Neck Tumors will be treated with SBRT.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

Malignant Tumors

Benign head and neck tumors will be treated with SBRT

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)

Malignant Head and Neck Tumors will be treated with SBRT.

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)

Unrescectable Malignant Tumors

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Mercy Research Manager - Regulatory Operations

12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Local Control Rate

12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Local Recurrence

Benign head and neck tumors will be treated with Stereotactic body radiotherapy

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Complication Rate

9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Overall Survival

Benign head and neck tumors will be treated with stereotactic body radiation therapy

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas	NCT04583384	Paraganglioma o...	1H-Spectroscopy...	18 Years -	Assistance Publique - Hôpitaux de Paris
Stereotactic Body Radiotherapy for Head and Neck Tumors	NCT01344356	Squamous Cell C... Nasopharyngeal ... Salivary Gland ... Head and Neck S... Paraganglioma o... Chordoma of Hea... Chondrosarcoma ... Angiofibroma of...	stereotactic bo... Stereotactic bo...	18 Years -	Mercy Research
In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas	NCT04583384	Paraganglioma o...	1H-Spectroscopy...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for paraganglioma of head and neck