Head and Neck Cancer Clinical Trial
— ACCRA-HNOfficial title:
Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.
Verified date | January 2014 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Signed written informed consent; - Males or females between 18 and 70 years of age; - Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks (maximum) ago; - To be categorized as high risk patients have to fulfil at least one of the following criteria: - R0 - resection <5 mm margin - R1 - resection - Extracapsular nodal extension; - no previous chemotherapy, radiotherapy; - Performance status ECOG: 0 - 1; - Contraception in male and female patients if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing; - Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery): - Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 10.0 g/dL - Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, ?-GT < 3 x ULN - Adequate renal function: creatinine clearance > =60 ml/min - No distant metastases; Exclusion Criteria: - Nasopharyngeal carcinoma; - R2 resection; - Invalid informed consent; - Performance Status > 1; - Previous chemotherapy or radiotherapy for carcinoma of the head and neck; - Prior exposure to EGFR pathway targeting therapy; - Other serious illness or medical conditions: - Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4; - Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal - Significant neurologic or psychiatric disorders including dementia or seizures; - Active uncontrolled infection; - Active disseminated intravascular coagulation; - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; - Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass; - Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days; - Known allergic/hypersensitivity reaction to any of the components of the treatment; - Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding; - Known drug abuse; - Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix; - Legal incapacity or limited legal capacity; - Sensitivity and incompatibility against 5-Fluorouracil - Sensitivity and incompatibility against platinum-compounds - Known incompatibilities >grade 3 towards cetuximab - expected incompliance of patient (e.g. in case of severe alcohol addiction) - Dental evaluation: Pre treatment dental care before start of radiochemotherapy (approximately 8 to 10 days lapse-time is needed for complete recovery before initiation of radiation therapy). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charité University Medicine, Department of Radiotherapy and Radiological Oncology | Berlin | |
Germany | Department of Radiotherapy an Radiological Oncology University Hospital Essen | Essen | NW |
Germany | Department of Radiotherapeutics of the University Hospital Freiburg | Freiburg | BW |
Germany | Department of Radiological Oncology University Hospital Heidelberg | Heidelberg | BW |
Germany | Department of Radiotherapy and Radiological Oncology Universität Hospital Jena | Jena | Thueringen |
Germany | Department of Radiotherapy, University Hospital Schleswig Holstein, Campus Lübeck | Lübeck | Schleswig Hostein |
Germany | Department of Radiotherapy and Radiological Oncology University Hospital Mainz | Mainz | Rheinland-Pfalz |
Germany | Department of Radiotherapy and Radiological Oncology, University Hospital Munich | Munich | Bavaria |
Germany | Department of Radiotherapy and Radiological Oncology University Hospital Tuebingen | Tuebingen | BW |
Germany | Department of Radiotherapy and Radiological Oncology University Hospital Ulm | Ulm | BW |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Budach W, Bölke E, Homey B. Severe cutaneous reaction during radiation therapy with concurrent cetuximab. N Engl J Med. 2007 Aug 2;357(5):514-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate. | any toxicities occurring within 90 days post radiation start | Yes | |
Secondary | Incidence of Loco-regional relapse | assessment after patient has completed follow-up | No | |
Secondary | Disease-free survival | time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death | No | |
Secondary | Progression-free survival | from start of surgery to the first observation of disease progression or death | No | |
Secondary | Overall survival | censored at the time of last documented efficacy | No | |
Secondary | The rate of patients with secondary primary neoplasm | assessment after patient has completed follow-up | Yes | |
Secondary | The incidence of late toxicity | beyond 90 days after start of radiation therapy | Yes |
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 |