Head and Neck Cancer Clinical Trial
Official title:
Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies
RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and
fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to
treatment and help plan the best treatment.
PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate
response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of
the oropharynx, larynx, or hypopharynx.
OBJECTIVES:
Primary
- To assess whether 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG)
PET scans can be used to identify patients with advanced squamous cell carcinoma of the
oropharynx, larynx, or hypopharynx who have a biochemical response after 2 weeks of
induction therapy with cetuximab.
- To assess whether FLT and FDG PET imaging-based response after 20-30 Gy of radiotherapy
is predictive of disease control at 6 months after completion of therapy.
Secondary
- To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or
20-30 Gy of radiotherapy is predictive of pathologic complete response in these
patients.
- To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or
20-30 Gy of radiotherapy is predictive of disease-free survival at 2 years in these
patients.
- To correlate suppression of FLT uptake after cetuximab therapy with thymidine kinase 1
activity and/or expression, proliferation, microvessel density, apoptosis, and signaling
pathway analyses.
- To correlate suppression of FDG uptake after cetuximab therapy with expression of
hexokinases, glucose transporter proliferation, microvessel density, apoptosis, and
signaling pathway analyses.
- To test and refine the ability of a novel commercial software package to quantify
treatment-induced structural and functional/molecular volumetric and sub-volumetric
change.
- To develop a working method for expressing change and predicting outcome.
OUTLINE: Patients receive cetuximab IV on days 1 and 8 of course 1. Beginning in course 2 and
all subsequent courses, patients receive cetuximab IV and cisplatin IV over 2 hours on day 1
and undergo radiotherapy once daily 5 days a week for 7 weeks. Treatment repeats every 7 days
for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo 3'-deoxy-3'-[18F] fluorothymidine and fludeoxyglucose F 18 (FDG) PET scans
at baseline, after the second dose of cetuximab, after 20-30 Gy of radiotherapy, and then at
6 weeks and 6 months after completion of radiotherapy.
Patients undergo tumor tissue biopsies at baseline and after the first dose of cetuximab for
correlative laboratory studies. Samples are analyzed for proliferation (Ki-67 labeling
index), microvessel density (CD-31 staining), apoptosis (TUNEL assay and caspase-3 by IHC)
signaling pathway (expression of EGFR, AKT, and MAPK by IHC), molecules affecting FDG uptake
(expression of GLUT1, GLUT3, and hexokinase by IHC), and thymidine kinase 1 activity or
expression.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
| Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
| Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
| Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
| Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
| Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
| Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
| Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
| Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |