AzTrials
AzTrials

Squamous Cell Carcinoma of the Head and NeckPhase 3CHANCENCT01012258

Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects

A Phase 3 study testing Cetuximab + concomitant boost radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 8 sites in China.

Completed

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

Official record
Search all trials

Trial summary

Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cetuximab + concomitant boost radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
8 sitesChina
Study dates
Feb 2009to May 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inpatient greater than or equal to (>=) 18 years of age
  • Pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx or larynx
  • Stage III or IV disease with an expected survival of at least 12 months
  • Medically suitable to withstand a course of concomitant boost RT
  • Presence of at least 1 bi-dimensionally measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified World Health Organization (WHO) criteria
  • Karnofsky Performance Status (KPS) >=80 at trial entry
Show all 13Show fewer
  • Neutrophils >=1.5*10^9/Liter (L), platelet count >= 100*10^9/L, hemoglobin >= 90 gram/liter (g/L)
  • Total bilirubin less than or equal to (<=) 2*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3*ULN
  • Serum creatinine <=133 micromole/liter (mcmol/L)
  • Serum calcium within normal range
  • Effective contraception if procreative potential exists (applicable to both male and female subjects)
  • Chinese with Chinese citizenship
  • Signed written informed consent

Who cannot join

  • Evidence of distant metastatic disease
  • Squamous cell carcinoma arising in the nasopharynx or oral cavity
  • Receipt of prior systemic chemotherapy within the last 3 years
  • Previous surgery for the tumor under study other than biopsy
  • Receipt of prior RT to the head and neck
  • Currently receiving RT as part of a postoperative regimen following primary surgical resection
Show all 19Show fewer
  • Planned neck dissection after trial RT
  • Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
  • Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
  • Uncontrolled hypertension defined as systolic blood pressure >=180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
  • Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
  • Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
  • Other concomitant anticancer therapies
  • Documented or symptomatic brain or leptomeningeal metastasis
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
  • Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
  • Evidence of previous other malignancy within the last 5 years
  • Intake of any investigational medication within 30 days before trial entry
  • Other protocol-defined exclusion criteria may apply

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Fujian Provincial Tumor Hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Zhejiang Provincial Cancer Hospital

    Hangzhou

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

Other trials in China

About this study

Official title: Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects

Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects.

Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects.

Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.

Being tested
Cetuximab + concomitant boost radiotherapy
Keywords
antitumor activity, safety, cetuximab in combination with radiotherapy, locally advanced squamous cell head & neck carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Cetuximab + concomitant boost radiotherapyBiological

    Also called Erbitux®

    Cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially

    • Once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by
    • Twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses are separated by at least a 6-hour interval
Study groups in NCT01012258
Study groupRoleWhat they receive
CetuximabExperimentalAll eligible subjects will receive cetuximab treatment only during week 1 of the treatment course and concomitant cetuximab and boost radiotherapy (RT) during week two to week seven of the treatment course
Receives: Biological: Cetuximab + concomitant boost radiotherapy

What is being measured

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

  1. Best Overall Response (BOR)

    Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.

    Measured: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit

Secondary outcomes (1)

  1. Progression-Free Survival (PFS)

    Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).

    Measured: Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant

Timeline

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

  1. First posted13 Nov 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionSep 2010
  4. Study completionMay 2014

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01012258
Sponsor's protocol ID
EMR62241-054
Acronym
CHANCE
Status last verified
Jun 2015
First submitted
10 Nov 2009
Last updated
9 Jul 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetuximab + concomitant boost radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 8 sites in China.

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 13 inclusion and 19 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Overall Response (BOR) (time frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit). 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 NCT01012258.

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 9 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in