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Esophageal CancerPhase 3TRAP-2NCT05188313

TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

A Phase 3 study testing Trastuzumab, Pertuzumab and Paclitaxel in people with Esophageal Cancer and Esophageal Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Esophageal Adenocarcinoma
What is being tested?
Trastuzumab, Pertuzumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
1 siteNetherlands
Study dates
9 Mar 2022to Feb 2037
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 esophagus or gastroesophageal junction, T1N+M0; or T2-T4a N0 or N+ M0).
  • HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the local laboratory on a primary tumor biopsy. HER2 status needs to be confirmed by the central laboratory, but does not affect start of treatment.
  • Surgical resectability, as determined during multidisciplinary meeting. Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.
  • If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction.
  • Age ≥ 18.
  • ECOG performance status 0 or 1 (cf. Appendix A).
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  • Adequate hematological, renal and hepatic functions defined as:
  • Neutrophils ≥ 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% determined by transthoracic echocardiography or MUGA.
  • Written, voluntary informed consent
  • Patients must be accessible to follow up and management in the treatment center

Who cannot join

  • T1N0 tumors or in situ carcinoma.
  • Past (within 5 years) or current history of malignancy other than entry diagnosis which has a worse expected prognosis than the current esophageal cancer.
  • Previous chemotherapy, radiotherapy, treatment with an anti-HER2 antibody or with small molecule HER2 inhibitors for esophageal cancer or for any other cancer within 6 months of diagnosis of esophageal cancer.
  • Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor.
  • Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
  • Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
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  • Not willing to use highly effective methods of contraception (per institutional standard) during treatment (male or female) and for 6 months after the end of treatment.
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
  • Pulmonary fibrosis and/or severely impaired lung function (FEV1 < 1,5L) precluding major surgery.
  • 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 despite consultation of a dietician and/or tube feeding.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
  • Evidence of acute or chronic infection with hepatitis B, C or HIV.
  • History of prior allogeneic stem cell or solid organ transplantation.
  • Pre-existing motor or sensory neurotoxicity greater than or equal to CTC AE grade 2.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site, 1 recruiting

  • Academic Medical Center

    Amsterdam, 1105 AZ

    H. WM van Laarhoven, M.D., PhD, 31 20 5665955, secr-onco@amc.uva.nl

    H. WM van Laarhoven, M.D., PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: The Efficacy of the Addition of TRAstuzumab and Pertuzumab to Neoadjuvant Chemoradiation: a Randomized Multi-center Study in Resectable HER2 Overexpressing Adenocarcinoma of the Esophagus or Gastroesophageal Junction. The TRAP-2 Study

Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. TRAP-2 aims to address these needs by investigating whether addition of trastuzumab and pertuzumab to standard of care improves survival of patients with resectable HER2 positive esophageal adenocarcinoma (HER2+ EAC). Patients with HER2+ EAC will be randomised to neoadjuvant chemoradiation according to the CROSS regimen or CROSS + TRAstuzumab and Pertuzumab. Primary outcome is overall survival.

Keywords
HER2
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

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

  • TrastuzumabDrug

    Intravenous administration of study drug

  • PertuzumabDrug

    Intravenous administration of study drug

  • PaclitaxelDrug

    Intravenous administration of study drug

  • CarboplatinDrug

    Intravenous administration of study drug

Study groups in NCT05188313
Study groupRoleWhat they receive
Chemoradiation according to the CROSS regimenActive comparatorPaclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29. A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
Receives: Drug: Paclitaxel; Drug: Carboplatin
Chemoradiation according to the CROSS regimen combined with trastuzumab and pertuzumabExperimentalPaclitaxel 50 mg/m2 and carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29. A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy. Pertuzumab will be administered intravenously first, on Day 1, 22, 43, 64, and 85 using a fixed dose of 840 mg. Trastuzumab will be administered intravenously on Day 1 of each treatment cycle, using an initial dose of 4 mg/kg on day 1, followed by doses of 2 mg/kg weekly up to week 6. From week 7 onwards trastuzumab will be administered at a dose of 6 mg/kg, every three weeks.
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Overall survival

    Overall survival will be calculated from the date of randomization to death.

    Measured: 5.5. years (maximum follow-up time)

Secondary outcomes (5)

  1. Progression free survival

    Progression free survival will be calculated from the date of randomization to death or progression.

    Measured: 5.5. years (maximum follow-up time)

  2. Adverse events

    Treatment toxicity according

    Measured: 15 weeks (duration of neoadjuvant treatment)

  3. Surgical complications

    Surgical complications according to Clavien Dindo

    Measured: 30 days after surgery

  4. Left Ventricular Systolic Dysfunction

    ≥ 10 percentage points decrease from baseline to an absolute value < 50%

    Measured: 5.5. years

  5. General quality of life

    Quality of life

    Measured: 5.5. years

Timeline

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

  1. First posted12 Jan 2022
  2. Study start9 Mar 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionFeb 2037 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188313
Sponsor's protocol ID
NL79276.018.21
Acronym
TRAP-2
Status last verified
Jun 2022
First submitted
27 Dec 2021
Last updated
24 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab, Pertuzumab and Paclitaxel in people with Esophageal Cancer and Esophageal Adenocarcinoma, 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 15 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Jun 2022. 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 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5.5. years (maximum follow-up time)). 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 NCT05188313.

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 24 Jun 2022.

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TRAP-2 Clinical Trial NCT05188313 | AzTrials