Head and Neck Cancer Clinical Trial
Official title:
Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
in different ways. Some block the ability of tumor cells to grow and spread. Others find
tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy
uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with
cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and
fluorouracil together with cetuximab and radiation therapy works in treating patients with
locally advanced head and neck cancer.
OBJECTIVES:
Primary
- Evaluate the progression-free survival of patients with locally advanced squamous cell
carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel,
cisplatin, and fluorouracil followed by concurrent cetuximab and radiotherapy.
Secondary
- Assess the objective response rate in patients treated with this regimen.
- Assess the best overall response rate, overall survival, local-regional control, and
distant failure in patients treated with this regimen.
- Assess the acute and long-term toxicity associated with this regimen in these patients.
- Assess quality of life and swallowing in patients treated with this regimen.
- Determine the accuracy of PET/CT scan in evaluating objective response; in detecting
residual disease at primary sites and nodes; in guiding the recommendation for salvage
surgery or for neck dissection; and in early detection of recurrent or metastatic
disease.
OUTLINE: Patients are stratified according to nodal status (N2b-c or N3 vs N0-2a), tumor
characteristics of invasiveness (present vs absent), human papilloma virus (HPV) status
(positive vs negative), and primary tumor site (hypopharynx vs larynx vs oropharynx).
Patients receive induction chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV
over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3
weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Beginning 3-4 weeks after completion of induction chemotherapy, patients receive cetuximab IV
once weekly for 7 weeks. Beginning 1 week after the first dose of cetuximab, patients undergo
concurrent intensity-modulated radiotherapy or conventional 3-dimensional radiotherapy once
or twice daily 5-6 days a week for up to 6 weeks. Patients with persistent disease undergo
salvage resection of the primary tumor and/or neck dissection approximately 3 months after
the completion of radiotherapy.
Patients undergo quality of life and swallowing evaluations periodically.
Patients undergo PET/CT scan at baseline, before beginning radiotherapy, at 6-8 weeks after
completion of study treatment, every 6 months for 5 years, and then annually thereafter.
After completion of study treatment, patients are followed at 4 and 8 weeks, every 2 months
for 2 years, every 3 months for 1 year, and then every 6 months thereafter.
;
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 |