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Locally Advanced Malignant NeoplasmPhase 2/3EAGLENCT01434394

Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

A Phase 2/3 study testing Neo-adjuvant Erbitux-based chemotherapy in people with Locally Advanced Malignant Neoplasm and Oral Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

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

EGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Neo-adjuvant Erbitux-based chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
1 siteChina
Study dates
Aug 2011to Feb 2017
Phase
Phase 2/3
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

  • Written informed consent prior to any study activities
  • Age 18-75
  • Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
  • Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
  • Karnofsky performance status (KPS) ≥70
  • Adequate hematologic function: Neutrophils ≥1,500/mm^3, WBC >4,000/mm^3, Hb > 10 g/dL, platelet count >100,000/mm^3
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  • Hepatic function: ALAT/ASAT <2.5 times the upper limit of normal (ULN), bilirubin <1.5 x ULN
  • Renal function: serum creatinine <1.5 x ULN
  • Life expectancy ≥6 months

Who cannot join

  • Evidence of distant metastatic disease and other oropharyngeal cancers
  • Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
  • Previous radiotherapy for the primary tumor or lymph nodes
  • Previous exposure to epidermal growth factor-targeted therapy
  • Prior chemotherapy or immunotherapy for the primary tumor
  • Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
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  • Any investigational agent prior to the 1st study medication
  • Participation in another clinical study within the 30 days prior to Inclusion in this study.
  • Peripheral neuropathy >grade 1
  • Known grade 3 or 4 allergic reaction to any of the study treatment
  • History of severe pulmonary or cardiac disease
  • Creatinine Clearance <30 ml/min
  • Know drug abuse /alcohol abuse
  • Legal incapacity or limited legal capacity
  • Active systemic infection
  • Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
  • Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period
  • Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

EGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.

Read the detailed description

The primary endpoint of this study is the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1, 3, 5 years), overall survival rate (3, 5 years), and the safety.

Being tested
Neo-adjuvant Erbitux-based chemotherapy
Keywords
Oral cancer, Oropharyngeal cancer, Induction chemotherapy, Targeted chemotherapy, Surgery, Radiotherapy
Medical subject headings
Mouth Neoplasms, Oropharyngeal Neoplasms

What participants receive

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

  • Neo-adjuvant Erbitux-based chemotherapyDrug

    Also called Followed by surgery and radiotherapy

    Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency \& treatment mode: Weekly Duration: 6 weeks

    Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

    Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)

Study groups in NCT01434394
Study groupRoleWhat they receive
Neo-adjuvant Erbitux-based chemotherapyExperimentalNeo-adjuvant Erbitus-based chemotherapy before surgery: Erbitus, Docetaxel, Cisplatin.
Receives: Drug: Neo-adjuvant Erbitux-based chemotherapy
Surgery and radiotherapyNo interventionSurgery and post-operative radiotherapy.

What is being measured

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

  1. Pathological Complete Response

    To evaluate pathological Complete Response (pCR) after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy.

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Disease Free Survival

    Disease Free Survival (DFS) rates (1, 2, 3, 5 years)

    Measured: 5 years

  2. Locoregional Control rates

    Locoregional Control rates (LCR) (1, 3, 5 years)

    Measured: 5 years

  3. Overall Survival

    Overall Survival (OS) rate (3, 5 years)

    Measured: 5 years

  4. Number of Participants with Adverse Events

    All Adverse Events(AEs),including Serious Adverse Events(SAEs), Exposure of All study drugs \& radiation

    Measured: 5 years

Timeline

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

  1. First posted14 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionOct 2014
  4. Study completionFeb 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01434394
Sponsor's protocol ID
9thShanghai
Other IDs
10DZ1951300
Acronym
EAGLE
Status last verified
May 2014
First submitted
2 Sep 2011
Last updated
21 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Neo-adjuvant Erbitux-based chemotherapy in people with Locally Advanced Malignant Neoplasm and Oral Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site 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 9 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 21 Aug 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 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 combined 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.

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?

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?

Pathological Complete Response (time frame: Up to 6 months). 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 NCT01434394.

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 21 Aug 2017.

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