Head Neck Cancer Clinical Trial
Official title:
A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation With Intratumoral Bleomycin Therapy or Surgery in Patients With Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of the Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx, or Larynx That Have Failed Primary Curative Therapy
The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In patients suitable for salvage surgery of their recurrent disease, the success rate for local control has been reported to be 40-50%. The surgical treatment of H&N SCC frequently results in significant loss of organ function (e.g., inability to swallow, speak, etc.) and/or permanent disfigurement. There is a compelling and unmet medical need for a local therapy that destroys tumors while preserving function status and appearance in patients with primary, recurrent, or metastatic H&N SCC. Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04566367 -
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
|
N/A | |
| Terminated |
NCT02521870 -
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05572684 -
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT02268344 -
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
|
N/A | |
| Recruiting |
NCT04858269 -
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
|
Phase 2 | |
| Recruiting |
NCT05878964 -
Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors.
|
||
| Recruiting |
NCT03051269 -
Calcium Electroporation for Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT05833841 -
Swallowing Function in Patients With Head and Neck Cancers
|
N/A | |
| Withdrawn |
NCT03747562 -
Study of Efficacy and Safety of Gabapentin to Reduce the Need for Strong Opioid Use in Head and Neck Cancer Patients.
|
Phase 3 | |
| Completed |
NCT03572829 -
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
|
Phase 2 | |
| Completed |
NCT02075385 -
Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer
|
Phase 2 | |
| Recruiting |
NCT02549742 -
Electrochemotherapy on Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01951664 -
Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
|
N/A | |
| Recruiting |
NCT05838729 -
Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03832686 -
Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer
|
N/A | |
| Recruiting |
NCT05382585 -
Newer Therapeutic Targets in Head and Neck Cancers
|