Chemoradiation Treatment for Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00704639
First received: June 22, 2008
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.

The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.


Condition Intervention Phase
Head and Neck Cancer
Drug: Cetuximab
Drug: Carboplatin
Radiation: Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Cetuximab, Carboplatin and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Safety and Feasibility [ Time Frame: An initial 6 patients will be treated. Once all these patients have a 2 week post RT review there will be analysis. If <= 1 patient has a DLT than the treatment is deemed safe. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Failure free survival (FFS) [ Time Frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment. ] [ Designated as safety issue: No ]
  • Time to local and/or regional failure [ Time Frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment. ] [ Designated as safety issue: No ]
  • Site of first failure [ Time Frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment. ] [ Designated as safety issue: No ]
  • Acute and late treatment toxicities [ Time Frame: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)
Drug: Cetuximab
Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy
Other Name: Erbitux
Drug: Carboplatin
Weekly intravenous carboplatin (AUC 2) for the duration of the RT
Other Name: Paraplatin
Radiation: Radiotherapy
The radiotherapy schedule will be the "infield boost" (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended).
Other Name: Radiotherapy

Detailed Description:

Secondary objectives are to estimate failure free survival (FFS) and overall survival, to evaluate the time to local and regional failure and to determine the site of first failure (characterised as local, regional, distant or combinations). Acute and late treatment toxicities will also be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated SCC of the oropharynx, larynx or hypopharynx.
  • Stage III or IV, excluding T1N1, and metastatic disease (to be confirmed by a chest CT, and abdominal CT or ultrasound scan if patients with abnormal liver function tests or a bone scan or FDG-PET if patients with bone pain).
  • Histologically or cytologically confirmed HNSCC
  • Disease must be considered potentially curable by chemoradiation
  • Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:

    • Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
    • Severe tinnitus
    • Renal impairment (GFR < 60ml/min)
    • Peripheral neuropathy > grade 2
    • Inability to tolerate intravenous hydration eg due to cardiac disease
    • Co-morbidities (based on clinical judgement by the investigator) associated with ECOG PS 2 that in the view of the investigator would preclude the safe administration of cisplatin
  • Performance status ECOG 0, 1 or 2.
  • Adequate haematological, renal and hepatic functions as defined by:

    • Absolute neutrophil count (ANC, segmented cells (segs) + bands)>= 1.5 x 109/L
    • Platelet count >= 100 x 109/L
    • Total bilirubin <= 1.5 x upper normal limit
    • Alanine aminotransferase <= 2.5 x upper normal limit
    • Calculated creatinine clearance > 40ml/min (Cockcroft-Gault formula).
    • If calculated creatinine clearance < 50 ml/min, glomerular filtration rate to be measured with DTPA or EDTA scan. If < 40 ml/min not eligible.
  • Age >18 years
  • Signed written consent
  • Suitable for follow-up for 4 years in the view of the investigator

Exclusion Criteria:

  • Distant metastases, i.e., any metastatic disease below the clavicles. Patients with lung nodules >10mm will be excluded unless non-malignancy aetiology is established. Patients with lesions 5-10mm can be included if a FDG-PET scan is negative and the investigator considers on clinical grounds that metastasis is unlikely. Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
  • Previous radical RT to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
  • Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
  • Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as HIV infection, cardiac failure, pulmonary compromise, active infection
  • Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
  • Pregnant or lactating women.
  • Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
  • High risk for poor compliance with therapy or follow up as assessed by the investigator
  • Prior radiation to greater than 30% of the bone marrow
  • Prior systemic chemotherapy for cancer
  • Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
  • Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704639

Locations
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: June Corry Peter MacCallum Cancer Centre, Australia
Study Chair: Danny Rischin Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00704639     History of Changes
Other Study ID Numbers: TROG 07.04
Study First Received: June 22, 2008
Last Updated: August 1, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Head and Neck
Cetuximab
Carboplatin
Radiotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014