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Oropharyngeal CancerPhase 2NCT01435252

A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

A Phase 2 study testing Cetuximab in people with Oropharyngeal Cancer and Hypopharyngeal Cancer, run by University of Zurich at 1 site in Switzerland.

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

Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled in this study. Patients are treated with standard chemoradiation in combination with concurrent add-on cetuximab. Read more about this study

Who is it for?
Ages 18 to 75 years
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
68 participants
Where
1 siteSwitzerland
Study dates
19 Sep 2011to 25 Oct 2017
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • T3-4 Nx M0; Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved) and/or total GTV > 70 cc (any T, any N, M0)
  • biopsy proven squamous cell cancer
  • primary tumor location in oral cavity, oropharynx, hypopharynx or larynx
  • Patients with CUP (cancer of unknown primary) syndrome in case they have advanced lymph node metastases (Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved).- Indication for chemoradiation (RT + Cisplatin)
  • curative treatment intent
  • Start of chemoradiation within the recruitment time frame
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  • Performance Status WHO/ECOG: 0-1
  • Age between 18 and 75 years
  • No previous chemotherapy or RT for cancer of the head and neck
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment
  • Patient must sign informed consent prior to study entry.

Who cannot join

  • Cancer of the nasopharynx
  • Any neoadjuvant chemotherapy prior to screening
  • Treatment with other investigational drugs within 4 weeks
  • History of malignancy other than basal cell skin cancer unless disease free for a minimum of 3 years.
  • Uncontrolled claudication, bleeding, or thromboembolic disorders at screening
  • Patients receiving heparin, warfarin or phenprocoumon therapy are ineligible- Uncontrolled and severe hypertension at screening according to the judgement of the investigator.
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  • Current uncontrolled cardiac disease: Unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, history of myocardial infarction within 12 months, significant arrhythmias
  • Left ventricular function < 45 % (determination of left ventricular function required when history of cardiac disease)
  • History of stroke within 6 months
  • Major surgical procedure, or significant traumatic injury within 28 days prior to screening; anticipation of need for major surgical procedure during the course of the study.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at screening
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at screening
  • Pregnant (positive pregnancy test) or lactating
  • Previous organ transplantation
  • Any immune suppressive therapy
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition because study treatment might be immuno-suppressive (Note: HIV testing only required if clinically indicated)
  • Any uncontrolled condition, which in the opinion of the investigator, would interfere with the safe and timely completion of study procedures.
  • Preexisting renal insufficiency with impaired creatinine clearance (<60ml/min) and/or increased plasma creatinine (>106 µmol/l) at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to screening
  • Serious, non-healing wound, ulcer, or bone fracture
  • AST, ALT, or bilirubin > 1.5 x normal
  • Preexisting absolute neutrophil count (ANC) < 1,800 cells/mm3
  • Platelets < 100,000 103/µl at screening
  • PTT > 1.5 x normal
  • WBC < 4000 103/µl
  • Hb < 11 g/dl at screening (Note: The use of transfusion or other intervention to achieve Hb > 11 g/dl is possible)
  • Contraindication to CDDP
  • Known allergy to cetuximab

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital

    Zurich

Other trials in Switzerland

About this study

Official title: A Phase II, Randomized, Open-Label, Single Center Study In Patients With Advanced Head And Neck Cancer To Investigate Efficacy And Safety Of Standard Chemoradiation And Add-On Concurrent Cetuximab ± Consolidation Cetuximab

Sixty patients with advanced squamous cell carcinomas of the head and neck will be enrolled in this study. Patients are treated with standard chemoradiation in combination with concurrent add-on cetuximab. Subsequently patients are randomized to cetuximab consolidation therapy (three months, Arm A) versus no consolidation therapy (Arm B). The aim of this study is to investigate if cetuximab consolidation therapy improves the 2-year locoregional control rate.

  • Trial with medicinal product
  • Trial with radiotherapy
Read the detailed description

This clinical study translates our preclinical findings that concurrent and consolidation cetuximab improves efficacy of RT into the clinic. It is a phase II, randomized, open-label, single center study in patients with locoregionally advanced stage III-IV and/or total gross tumor volume (tGTV) > 70cc head and neck cancer. This study population is at high risk for locoregional recurrence after chemoradiation alone. Tumor stages to be included are T3-4 Nx, Tx N2b-N3 (N2b only if ≥ 3 ipsilateral nodes involved) M0 and/or tGTV >70 cc (any T, any N, M0) squamous cell cancers of the head and neck (HNSCC). All patients will receive in, the so called 'Induction Phase' standard chemoradiation (RT up to 70 Gy in combination with weekly CDDP 40 mg/m2) and add-on concurrent cetuximab (loading Dose 400 mg/m2, concurrent dose 250 mg/m2 weekly). The patients are randomized to either add-on consolidation cetuximab (500 mg/m2 biweekly x 6 over 12 weeks) (Arm A) or no further treatment (Arm B). Randomization will take place after Induction Phase. The total number of patients to be included into the study is 60 (30 patients per arm). Up to 6 patients may be replaced in case of early drop out to reach that aim.

The sample size of 60 patients is considered to be sufficient to collect first information on clinical efficacy and the possible impact of various biomarkers on clinical endpoints. If the results of this study will demonstrate that the novel treatment regimen is safe and efficacious, a randomized multicenter phase III study will follow.

Being tested
Cetuximab
Medical subject headings
Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

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

  • CetuximabDrug

    Also called Erbitux®

    Arm A: chemoradiation in combination with concurrent cetuximab Arm B: chemoradiation in combination with concurrent and consolidation cetuximab

Study groups in NCT01435252
Study groupRoleWhat they receive
Arm AExperimentalPatients will be treated with chemoradiation in combination with concurrent cetuximab. Two weeks after end of chemoradiation the consolidation phase will start and patients will receive biweekly consolidation cetuximab, maximally 6 infusions over 12 weeks.
Receives: Drug: Cetuximab
Arm BExperimentalPatients will be treated with chemoradiation in combination with concurrent cetuximab.
Receives: Drug: Cetuximab

What is being measured

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

  1. Locoregional tumor control

    Measured: 2 years

Secondary outcomes (6)

  1. Progression free survival (PFS)

    Measured: 2 years

  2. Overall survival (OS)

    Measured: 2 years

  3. Metastasis rate

    Measured: 2 years

  4. Metastasis free survival (MFS)

    Measured: 2 years

  5. Biological surrogate markers

    Measured: 2 years

  6. Safety and tolerability

    Measured: 2 years

Timeline

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

  1. First posted16 Sep 2011 (estimated)
  2. Study start19 Sep 2011
  3. Primary completion25 Oct 2017
  4. Study completion25 Oct 2017

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435252
Sponsor's protocol ID
Add-On cetuximab
Status last verified
Nov 2017
First submitted
26 Jul 2011
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • de Galiza Barbosa F, Riesterer O, Tanadini-Lang S, Stieb S, Studer G, Pruschy M, Huber GF, Huellner MW, Stolzmann P, Veit-Haibach P. Evaluation of 18F-FDG PET/CT as an early imaging biomarker for response monitoring after radiochemotherapy using cetuximab in head and heck squamous cell carcinoma. Head Neck. 2020 Feb;42(2):163-170. doi: 10.1002/hed.25975. Epub 2019 Nov 9.

    PubMed 31705729

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Oropharyngeal Cancer and Hypopharyngeal Cancer, run by University of Zurich at 1 site in Switzerland.

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 11 inclusion and 28 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

Locoregional tumor control (time frame: 2 years). 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 NCT01435252, 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 6 Nov 2017.

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