Head and Neck Cancer Clinical Trial
Official title:
Skin Reaction to Cetuximab as Criteria for Treatment Selection in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase 2 Study
The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin.
Background: According to literature, the treatment results in irradiated patients who
develop intensive skin reaction after concomitant Cetuximab administration appear improved
as compared to the results of standard combination of radiotherapy and Cisplatin. In other
patients, no beneficial effect of Cetuximab is expected and the therapy with Cisplatin
(concomitantly with irradiation) is more effective in this group.
In this proposed single-institution non-randomized phase II study on patients with locally
advanced squamous cell carcinoma of the head and neck, the therapy will be adjusted to the
grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e.
either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy
(radiotherapy and Cisplatin).
Methods: In the patients with inoperable tumors, induction chemotherapy (Docetaxel 75 mg/m2,
Cisplatin 75 mg/m2, 5-Fluorouracil 750 mg/m2 in continuous infusion days 1-5; repeated every
21 days for 4 cycles) will be administered. In the week before the first fraction of
radiotherapy, all patients will receive a loading dose of Cetuximab (400 mg/m2) and
combination of Cetuximab (250 mg/m2) and Cisplatin (30 mg/m2) during the first week of
irradiation. After multidisciplinary assessment of the grade of skin rush, conducted at the
end of the second week of irradiation, the patients will be grouped as follows: arm A - skin
rush of CTCAE v3.0 grade <2 will proceed with radiochemotherapy with Cisplatin; arm B - skin
rush of CTCAE v3.0 grade >=2 will proceed with radioimmunotherapy with Cetuximab.
The planned number of patients included in the study is 120 (arm A - 50, arm B - 70) and
recruitment period is 3 years. The primary objective of the study is to determine
radiologically the complete response rate 12-14 weeks after therapy. The secondary
objectives are locoregional control, progression-free survival and overall survival at 2
years after therapy, acute and late toxicity.
Expected results: The expected complete response rate in patients treated with
radiochemotherapy and those treated with radioimmunotherapy is 50% and 75%, respectively. We
also expect the difference in an absolute survival gain between the groups to be 25%.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |