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AzTrials

Esophageal CarcinomaPhase 1/2TRAPNCT02120911

Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma

A Phase 1/2 study testing Pertuzumab, trastuzumab in people with Esophageal Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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

Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the setting of advanced disease and disease and safety of combining trastuzumab with chemoradiation in the curative setting has been established. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Carcinoma
What is being tested?
Pertuzumab, trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
Jan 2014to Feb 2017
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven adenocarcinoma of the intrathoracic esophagus or gastro esophageal junction.
  • HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the sponsor-designated central laboratory (pathology AMC) on a primary tumor biopsy.
  • Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and CT scan of neck, thorax and abdomen.
  • T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible.
  • Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm.
  • If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach.
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  • No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
  • Age ≥ 18 and ≤ 75 years.
  • ECOG performance status 0 or 1.
  • Adequate hematological, renal and hepatic functions defined as:
  • neutrophiles ≥ 1.5 x 109/L
  • platelets ≥ 100 x 109/L
  • hemoglobin ≥ 5.6 mmol
  • total bilirubin ≤ 1.5 x upper normal limit
  • creatinine clearance (Cockroft) > 60 ml/min
  • Adequate left ventricular ejection fraction defined as an LVEF of ≥55%.
  • Written, voluntary informed consent.
  • Patients must be accessible to follow up and management in the treatment center.

Who cannot join

  • A tumour the epicenter of which in the stomach is greater than 5 cm of the GE junction or those within 5 cm of the GE junction without extension in the oesophagus are classified as gastric cancer.
  • Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment.
  • Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
  • Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
  • Previous chemotherapy, radiotherapy, treatment with an anti-HER2 antibody or with small molecule HER2 inhibitors.
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization.
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  • Pulmonary fibrosis and/or severely impaired lung function.
  • Pre-existing motor or sensory neurotoxicity greater than WHO grade 1.
  • Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
  • Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  • Inadequate caloric- and/or fluid intake.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic Medical Center, Medical Oncology

    Amsterdam, 1100 DD

Other trials in Netherlands

About this study

Official title: Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+Esophageal Carcinoma: the TRAP Study

Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the setting of advanced disease and disease and safety of combining trastuzumab with chemoradiation in the curative setting has been established. In breast cancer, the added value of pertuzumab to standard treatment with trastuzumab has been shown both in the neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this setting is limited, and no data are available on the safety of this combination prior to major surgery, we propose to first conduct a feasibility study with this treatment stratgy. When the results of this study show that this treatment strategy is feasible, we will subsequently design a prospective study with efficacy as primary endpoint.

Read the detailed description

Objective of the study:

Assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery.

Study design:

This is a non-randomized feasibility study with Paclitaxel (T), Carboplatin (C), Pertuzumab (P). Trastuzumab (H), and radiation (RT) followed by surgical resection of the oesophagus.

Study population:

Patients (male/female) with histologically proven adenocarcinoma of the intrathoracic esophagus or gastro esophageal junction, age >18 and <75 years.

Intervention (if applicable):

Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29.

Trastuzumab will be administered at a dose of 4 mg/kg on day 1, followed by 2 mg/kg at wk 2-6. From wk 7 onwards trastuzumab is administered at a dose of 6 mg/kg every 3 weeks. Pertuzumab will be given 840 mg intravenously at each administration.

Thus, trastuzumab and pertuzumab will be continued during eight weeks after the end of chemoradiation. Surgery will be planned in or around week 14, approximately eight weeks after the end of chemoradiation.

Being tested
Pertuzumab, trastuzumab
Keywords
Her2+, Resectable esophageal carcinoma, Pertuzumab, Trastuzumab
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Pertuzumab, trastuzumabDrug

    Also called Perjeta, Herceptin

    Pertuzumab and trastuzumab will be combined with standard chemoradiation with carboplatin and paclitaxel.

Study groups in NCT02120911
Study groupRoleWhat they receive
Pertuzumab, trastuzumabExperimentalPertuzumab, trastuzumab
Receives: Drug: Pertuzumab, trastuzumab

What is being measured

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

  1. % of patients completing trastuzumab and pertuzumab treatment.

    See title

    Measured: up to 14 weeks after start of treatment

Secondary outcomes (5)

  1. Toxicity of pertuzumab and trastuzumab alone and in combination with chemoradiation

    See title

    Measured: up to 14 weeks after start of treatment

  2. Number of post-operative complications

    See title

    Measured: up to 3 months after surgery

  3. Pathological response

    See title

    Measured: up to 2 weeks after surgery

  4. R0 resection rate

    See title

    Measured: up to 2 weeks after surgery

  5. Pharmacokinetics of pertuzumab and trastuzumab

    See title

    Measured: up to 14 weeks after start of treatment

Timeline

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

  1. First posted23 Apr 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2017
  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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120911
Sponsor's protocol ID
AMCMEDONC 2013-377
Other IDs
2013-004111-42
Acronym
TRAP
Status last verified
Jun 2020
First submitted
15 Apr 2014
Last updated
1 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Stroes CI, Schokker S, Creemers A, Molenaar RJ, Hulshof MCCM, van der Woude SO, Bennink RJ, Mathot RAA, Krishnadath KK, Punt CJA, Verhoeven RHA, van Oijen MGH, Creemers GJ, Nieuwenhuijzen GAP, van der Sangen MJC, Beerepoot LV, Heisterkamp J, Los M, Slingerland M, Cats A, Hospers GAP, Bijlsma MF, van Berge Henegouwen MI, Meijer SL, van Laarhoven HWM. Phase II Feasibility and Biomarker Study of Neoadjuvant Trastuzumab and Pertuzumab With Chemoradiotherapy for Resectable Human Epidermal Growth Factor Receptor 2-Positive Esophageal Adenocarcinoma: TRAP Study. J Clin Oncol. 2020 Feb 10;38(5):462-471. doi: 10.1200/JCO.19.01814. Epub 2019 Dec 6.

    PubMed 31809243

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pertuzumab, trastuzumab in people with Esophageal Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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 18 inclusion and 11 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 1 Jul 2020. 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

% of patients completing trastuzumab and pertuzumab treatment. (time frame: up to 14 weeks after start of treatment). 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 NCT02120911, 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 1 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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