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Head and Neck CancerPhase 2NCT01472653

Treatment Selection According to Skin Reaction to Cetuximab

A Phase 2 study testing cisplatin, radiotherapy and cetuximab in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. 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?
cisplatin, radiotherapy and cetuximab
How many people
120 participants
Where
1 siteSlovenia
Study dates
Dec 2011to Dec 2016
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

  • Squamous cell carcinoma, histologically proven (with HPV-status determined in patients with oropharyngeal primary)
  • Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
  • Locally and/or regionally operable and inoperable tumors (UICC TNM stages III, IVa or IVb), without distant metastases (M0-stage)
  • Male or female ≥18 years of age
  • Expected survival >6 months
  • WHO performance status 0-2
Show all 11Show fewer
  • Laboratory parameters:
  • hemoglobin ≥100 g/L; leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L; platelet count > 100x109/L; total bilirubin < 1.25x upper normal limit; transaminases (ALT, AST) < 5x upper normal limit; creatinine clearance (ECC) ≥ 60 ml/minute;
  • Presence of at least one bidimensionally measurable index lesion
  • Effective contraception for both male and female subjects if risk of conception exists
  • Signed written informed consent

Who cannot join

  • Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix
  • Chemotherapy ineligibility:
  • unstable cardiopulmonary, renal and liver disease likely to compromise the safe delivery of I.V. infusion (chemotherapy); haematologic diseases; clinically evident hearing impairment; pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0; previous administration of Cetuximab or Cisplatin;
  • Active, uncontrolled infection
  • Medical or psychological condition which in the opinion of the investigator precludes the safe administration of the planned radiotherapy or systemic therapy
  • Known drug abuse or severe alcohol abuse
  • Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country.

Primož Strojan, Prof. contact

pstrojan@onko-i.si

Slovenia1 site, 1 recruiting

  • Institute of Oncology Ljubljana

    Ljubljana, SI-1000

    Primož Strojan, Prof., pstrojan@onko-i.si

    Marta Dremelj, MD, MSc

    Recruiting

Other trials in Slovenia

About this study

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.

Read the detailed description

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%.

Being tested
cisplatin, radiotherapy, cetuximab
Keywords
Head and neck Cancer, Radiochemotherapy, Radioimmunotherapy, Skin rush, locoregional control, Survival, Toxicity
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.

  • cisplatinDrug

    cisplatin 30 mg/m2/week I.V. during radiotherapy

  • radiotherapyRadiation

    3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks

  • cetuximabDrug

    Also called Erbitux

    cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week I.V. during radiotherapy

What is being measured

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

  1. locoregional complete response rate

    The primary objective of the study is to determine radiologically the complete response rate 12-14 weeks after therapy.

    Measured: 12-14 weeks after therapy

Secondary outcomes (5)

  1. feasibility (toxicity profile) of the proposed regimen

    number of patients with adverse events graded according to the National Cancer Institute CTC v3.0 (as measure of safety and tolerability)

    Measured: participants will be followed for the duration of treatment (an expected average of 20 weeks)

  2. locoregional control

    Locoregional control will be calculated from the first day of the therapy to the occurrence of the local and/or regional recurrence (whichever will occur first) or death from any cause other than distant metastasis.

    Measured: at 2 years after thapy

  3. progression-free survival

    Progression-free will be calculated from the first day of the therapy to the appearance of local or regional recurrence, distant metastases, secondary primary cancer or death from any cause.

    Measured: 2 years after therapy

  4. overall survival

    Overall survival is defined as a time interval between the first day of therapy and death from any cause.

    Measured: 2 years after therapy

  5. late toxicity including thyroid function

    number of patients with adverse events graded according to the National Cancer Institute CTC v3.0 (as measure of safety and tolerability)

    Measured: up to 2 years post-therapy

Timeline

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

  1. First posted16 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2014 (estimated)
  4. Study completionDec 2016 (estimated)

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472653
Sponsor's protocol ID
ORL-01-11
Status last verified
Dec 2011
First submitted
23 Oct 2011
Last updated
13 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, radiotherapy and cetuximab in people with Head and Neck Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.

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 7 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: status not confirmed, as of the sponsor's last update on 13 Dec 2011. 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 Slovenia. 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?

Results are not available in the source record.

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

Contact Primož Strojan, Prof. (pstrojan@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

locoregional complete response rate (time frame: 12-14 weeks after therapy). 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 NCT01472653.

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 13 Dec 2011.

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