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Esophageal Adenocarcinoma (UICC TNM7)Phase 3ESOPECNCT02509286

Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Oxaliplatin in people with Esophageal Adenocarcinoma (UICC TNM7) and Adenocarcinoma of the Esophagogastric Junction, run by University Hospital Schleswig-Holstein at 30 sites in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
5-Fluorouracil, Leucovorin and Oxaliplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
30 sitesGermany
Study dates
Jan 2016to 31 Dec 2024
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7)
  • Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0
  • Age ≥18 years
  • No prior abdominal or thoracic radiotherapy
  • ECOG Performance status 0-2
  • Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review)
Show all 11Show fewer
  • Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l)
  • Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1 >65% of predicted)
  • Adequate renal function (GFR >60ml/min)
  • Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard)
  • written informed consent

Who cannot join

  • Tumors of squamous or other non-adenocarcinoma histology
  • Patients with advanced inoperable or metastatic esophageal adenocarcinoma
  • Stage cT1N0 and cT4b
  • Gastric carcinoma
  • Prior chemotherapy for cancer,
  • Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
  • Clinical significant lung disease (FEV1 <65% of predicted)
  • Peripheral neuropathy Grade >1

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Germany30 sites

  • Uniklinik RWTH Aachen

    Aachen

  • Charité Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12203

  • Charité Berlin Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • Uniklinik Köln

    Cologne, 50937

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 03107

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Universitätsmedizin Göttingen

    Göttingen, 37099

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universitätsmedizin Mainz

    Mainz

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinikum der Universität München (LMU)

    München

  • Universitätsklinikum Münster

    Münster

  • Ruppiner Kliniken GmbH

    Neuruppin, 16816

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Universitätsmedizin Rostock

    Rostock, 18059

  • Klinikum Stuttgart

    Stuttgart, 70174

  • Robert-Bosch-Krankenhaus Stuttgart

    Stuttgart, 70376

  • Klinikum Mutterhaus

    Trier, 54290

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus

The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.

Read the detailed description

According to the given evidence a survival benefit of perioperative chemotherapy (periCTX) over Neoadjuvant chemoradiation (neoCRT) for patients with Esophageal adenocarcinomas (EAC) has not been proven in any randomized controlled trials (RCT). Data supporting the value of periCTX have all been obtained in studies including mixed patient cohorts with EAC and gastric adenocarcinoma (GAC). Due to relevant differences of histologic subtype distribution, response to periCTX and survival rates between EAC and GAC there is a clear need to obtain evidence concerning the value of periCTX for EAC. As nowadays periCTX is extensively and successfully applied in clinical practice in patients with EAC there is an obvious need to obtain evidence from a multicentre RCT. Moreover a confirmation of the superior survival rates of the recent RCT on neoCRT should be obtained in a RCT conducted exclusively on EAC. Therefore, this prospective RCT with the primary objective of longterm patient survival comparing periCTX and neoCRT was designed.

Translational Projects:

Project 1+2: Circulating Tumor Cells as Biomarker in EAC CTC laboratories at University of Hamburg and University of Freiburg Project 3: Prognostic and predictive biomarkers in EAC University of Leipzig, UCCL

Keywords
Esophageal neoplasms, gastro-esophageal junction neoplasms, adenocarcinoma, esophagectomy, surgery, radiotherapy, chemotherapy
Medical subject headings
Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Adenocarcinoma

What participants receive

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

  • 5-FluorouracilDrug

    2600 mg/m² (24 hours), d1 every two weeks;

  • LeucovorinDrug

    200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;

  • OxaliplatinDrug

    85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;

  • DocetaxelDrug

    50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;

  • CarboplatinDrug

    Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.

  • PaclitaxelDrug

    50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;

  • Neoadjuvant radiationRadiation

    41.4Gy given in 23 fractions of 1.8Gy on days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31.

Study groups in NCT02509286
Study groupRoleWhat they receive
Perioperative Chemotherapy (FLOT):ExperimentalThe FLOT Arm consists of the FLOT protocol, which consists of 5-Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel. Repetition every 2 weeks (d15, q2w). Four neoadjuvant cycles (8 weeks) prior to surgery and four adjuvant cycles (8 weeks) postoperatively are given. Surgery is carried out by transthoracic subtotal esophagectomy or by transabdominal distal esophageal resection plus gastrectomy depending on tumor localization.
Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel
Neoadjuvant Chemoradiation (CROSS):Active comparatorThe CROSS Arm consists of the CROSS protocol, which consists of neoadjuvant radiation therapy (41.4Gy / 23fractions) and concurrent chemotherapy with Carboplatin and Paclitaxel (5 weeks) prior to surgery. Surgery is carried out by transthoracic subtotal esophagectomy or by transabdominal distal esophageal resection plus gastrectomy depending on tumor localization.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Neoadjuvant radiation

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 as time from start of study treatment to death due to any cause.

    Measured: At end of trial- up to 3 years in follow up

Secondary outcomes (6)

  1. Progression free survival time (PFS)

    PFS will be calculated as the time interval from randomisation to the first event of locoregional failure, metastatic progression or death.

    Measured: From randomisation up to 3 years in follow up

  2. Site of failure: local, regional or distant Failure

    Measured: From time of surgery up to 3 years in follow up

  3. Recurrence free survival time

    RFS will be calculated in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whatever comes first.

    Measured: From time of surgery up to 3 years in follow up

  4. Postsurgical Quality of Life

    Measured: From randomization up to 3 years in follow up

  5. Postoperative complications

    Measured: From time of surgery up to 90 days postoperatively

  6. Non-surgical site complications

    Measured: From time of surgery up to 90 days postoperatively

Timeline

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

  1. First posted28 Jul 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion1 May 2024 (estimated)
  4. Study completion31 Dec 2024 (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
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02509286
Sponsor's protocol ID
P000760
Other IDs
2015-001683-20, DRKS00008008, 2015
Acronym
ESOPEC
Status last verified
May 2024
First submitted
22 Jul 2015
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Hoeppner J, Lordick F, Brunner T, Glatz T, Bronsert P, Rothling N, Schmoor C, Lorenz D, Ell C, Hopt UT, Siewert JR. ESOPEC: prospective randomized controlled multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (NCT02509286). BMC Cancer. 2016 Jul 19;16:503. doi: 10.1186/s12885-016-2564-y.

    PubMed 27435280

  • Hoeppner J, Brunner T, Schmoor C, Bronsert P, Kulemann B, Claus R, Utzolino S, Izbicki JR, Gockel I, Gerdes B, Ghadimi M, Reichert B, Lock JF, Bruns C, Reitsamer E, Schmeding M, Benedix F, Keck T, Folprecht G, Thuss-Patience P, Neumann UP, Pascher A, Imhof D, Daum S, Strieder T, Krautz C, Zimmermann S, Werner J, Mahlberg R, Illerhaus G, Grimminger P, Lordick F. Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer. N Engl J Med. 2025 Jan 23;392(4):323-335. doi: 10.1056/NEJMoa2409408.

    PubMed 39842010

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fluorouracil, Leucovorin and Oxaliplatin in people with Esophageal Adenocarcinoma (UICC TNM7) and Adenocarcinoma of the Esophagogastric Junction, run by University Hospital Schleswig-Holstein at 30 sites in Germany.

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 8 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. 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?

Results are not available in the source record.

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?

Overall survival (time frame: At end of trial- up to 3 years in follow up). 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 NCT02509286, which also lists 2 linked publications.

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 8 May 2024.

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