Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT06236464 -
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
|
||
| Terminated |
NCT04659369 -
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT02572778 -
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
|
||
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Terminated |
NCT01488318 -
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT00999700 -
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
|
Phase 3 | |
| Completed |
NCT02565758 -
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02543476 -
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
|
N/A | |
| Recruiting |
NCT03938012 -
Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma
|
||
| Terminated |
NCT02124850 -
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
|
Phase 1 | |
| Active, not recruiting |
NCT03313804 -
Priming Immunotherapy in Advanced Disease With Radiation
|
Phase 2 | |
| Recruiting |
NCT05208762 -
A Study of SGN-PDL1V in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04453046 -
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
|
N/A | |
| Completed |
NCT01758731 -
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
|
Phase 1 | |
| Completed |
NCT02473731 -
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients
|
Phase 1 | |
| Completed |
NCT02022098 -
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
|
N/A | |
| Completed |
NCT01458392 -
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Completed |
NCT02882308 -
Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.
|
Phase 2 |