Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Prospective Randomized Pilot Clinical Trial of Margin-Based Vs. Robust Photon Radiotherapy Planning in Intensity-Modulated Radiation Therapy of Squamous-Cell Carcinoma of the Head and Neck
This is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (HN-SQCC). This study will compare the side effects experienced based on the method to plan radiotherapy, Margin Based or Robust.
This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. Intensity-modulated radiation therapy (IMRT) and standard chemotherapy will be used. QOL (quality of life) will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and EORTC QLQ-H&N35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. Xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) LENT/SOMA grading system and the University of Michigan's Xerostomia Questionnaire (XQ). The data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of HN-SQCC. ;
| 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 |