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Head and Neck CancerPhase 2ACCRA-HNNCT00791141

Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer

A Phase 2 study testing Cetuximab in people with Head and Neck Cancer, run by Heinrich-Heine University, Duesseldorf at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
10 sitesGermany
Study dates
Aug 2008to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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, γ-GT < 3 x ULN
  • Adequate renal function: creatinine clearance > =60 ml/min
  • No distant metastases;

Who cannot join

  • 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;
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  • 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 β-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).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Charité University Medicine, Department of Radiotherapy and Radiological Oncology

    Berlin, State of Berlin, 13353

  • Department of Radiotherapy an Radiological Oncology University Hospital Essen

    Essen, North Rhine-Westphalia, 45122

  • Department of Radiotherapeutics of the University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Department of Radiological Oncology University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Department of Radiotherapy and Radiological Oncology Universität Hospital Jena

    Jena, Thuringia, 07743

  • Department of Radiotherapy, University Hospital Schleswig Holstein, Campus Lübeck

    Lübeck, Schleswig Hostein, 23538

  • Department of Radiotherapy and Radiological Oncology University Hospital Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Department of Radiotherapy and Radiological Oncology, University Hospital Munich

    Munich, Bavaria, 81377

  • Department of Radiotherapy and Radiological Oncology University Hospital Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Department of Radiotherapy and Radiological Oncology University Hospital Ulm

    Ulm, Baden-Wurttemberg, 89091

Other trials in Germany

About this study

Official 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.

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.

Read the detailed description

Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and loco-regional recurrence frequently occurs. Efforts have been made to improve response rates and survival and different therapeutic regimens including concurrent chemo-radiotherapy or sequential chemo-radiotherapy have been developed.

To further increase the outcome of patients with locally advanced SCCHN effective new treatments with minimal toxicities are needed. Molecular targeted agents, which do not demonstrate overlapping toxicities with commonly used chemotherapy agents, have therefore been investigated. The EGFR is widely expressed at high levels in SSCHN and is associated with poor prognosis.

Cetuximab has already been investigated in combination with radiotherapy or chemotherapy in patients with head and neck cancer. The immunoradiotherapy was well tolerated with most of the side effects related to the high dose irradiation. The most common side effects are mucositis and dysphagia. Additionally, skin reactions appear sometimes more frequently in cetuximab administration. Grade 3 to 4 infusion reactions were observed in 3% of the patients treated with cetuximab. Based on the current promising results with RCT in patients with locally advanced head and neck cancer and clinical results with EGFR-antibodies plus RT, the present study was primarily designed to define the acute grade 3/4 toxicity.

We expect to show effective results in reducing the risk of distant metastasis, with administration of an additional six month adjuvant cetuximab treatment, in patient with recurrent SCCHN.

Being tested
Cetuximab
Keywords
Head and Neck Cancer, Radiation therapy, Chemotherapy, Chemoradiotherapy, adjuvant cetuximab administration
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Also called Erbitux

    Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.

Study groups in NCT00791141
Study groupRoleWhat they receive
CetuximabExperimentalCetuximab in combination with radiotherapy, cisplatin and 5-FU. After chemoradiotherapy all patients receive a cetuximab maintenance therapy.
Receives: Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: any toxicities occurring within 90 days post radiation start

Secondary outcomes (6)

  1. Incidence of Loco-regional relapse

    Measured: assessment after patient has completed follow-up

  2. Disease-free survival

    Measured: time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death

  3. Progression-free survival

    Measured: from start of surgery to the first observation of disease progression or death

  4. Overall survival

    Measured: censored at the time of last documented efficacy

  5. The rate of patients with secondary primary neoplasm

    Measured: assessment after patient has completed follow-up

  6. The incidence of late toxicity

    Measured: beyond 90 days after start of radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionApr 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00791141
Sponsor's protocol ID
ACCRA-HN
Acronym
ACCRA-HN
Status last verified
Jan 2014
First submitted
13 Nov 2008
Last updated
23 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Budach W, Bolke E, Homey B. Severe cutaneous reaction during radiation therapy with concurrent cetuximab. N Engl J Med. 2007 Aug 2;357(5):514-5. doi: 10.1056/NEJMc071075. No abstract available.

    PubMed 17671265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Head and Neck Cancer, run by Heinrich-Heine University, Duesseldorf at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: any toxicities occurring within 90 days post radiation start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00791141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.

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