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Adenocarcinoma of the Gastroesophageal JunctionPhase 2HerFLOTNCT01472029

Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach

A Phase 2 study testing 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab and Post-operative treatment trastuzumab mono therapy in people with Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma of the Stomach, run by AIO-Studien-gGmbH at 1 site in Germany.

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

The purpose of this study is to determine the rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab and Post-operative treatment trastuzumab mono therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteGermany
Study dates
Dec 2011to 12 Sep 2016
Phase
Phase 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 confirmed adenocarcinoma of the gastroesophageal junction (AEG I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications: Endosonography and an esophageal-gastro-duodenoscopy; Categorization of gastroesophageal junction tumors according to the classification by Siewert (1987, cf. appendix 2)
  • Detection of an adenocarcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by FISH, SISH or CISH by an accredited local pathologist (for quality assurance tumor samples have to be available for a subsequent central review)
  • No preceding cytotoxic or targeted therapy
  • Male and female patients aged ≥ 18 years. If able to reproduce, patients must be willing to use highly effective methods of contraception during treatment and for 6 months after the end of treatment (adequate: methods fulfilling the requirements of the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals [CPMP/ICH/286/95 mod]). Female patients with reproductive ability must have performed a negative pregnancy test within 7 days of study entry.
  • ECOG ≤ 2
  • Exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI (if osseous lesions are suspected due to clinical signs)
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  • Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically
  • Adequate haematological, hepatic and renal function parameters: Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm3; Serum creatinine ≤ 1.5 x upper limit of normal, or GFR > 40 ml/min; Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.5 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal
  • Normal cardiac ejection fraction, as assessed by echocardiography
  • Written patient consent form

Who cannot join

  • Known hypersensitivity against trastuzumab, murine proteins, 5-FU, leucovorin, oxaliplatin or docetaxel
  • Other known contraindications against trastuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
  • Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
  • Clinically significant valvular defect
  • Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
  • Known brain metastases
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  • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
  • Other severe internal disease or acute infection
  • Peripheral polyneuropathy > NCI Grade II
  • Chronic inflammatory bowel disease
  • On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
  • Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
  • Any other concurrent antineoplastic treatment including irradiation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Tagestherapiezentrum am ITM & III. Medizinische Klinik Universitätsmedizin Mannheim

    Mannheim, D-68167

Other trials in Germany

About this study

Official title: Multicenter, Explorative Phase II Study of Perioperative 5-FU, Leucovorin, Docetaxel, and Oxaliplatin (FLOT) in Combination With Trastuzumab in Patients With HER2-positive, Locally Advanced, Resectable Adenocarcinoma of the Gastroesophageal Junction or Stomach (HerFLOT)

The purpose of this study is to determine the rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist.

Being tested
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab, Post-operative treatment trastuzumab mono therapy
Keywords
Adenocarcinoma, Gastroesophageal junction, Stomach, HER2
Medical subject headings
Adenocarcinoma

What participants receive

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

  • 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumabDrug

    Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:

    Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle

    Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle

    Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle

    Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle

    5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle

  • Post-operative treatment trastuzumab mono therapyDrug

    Trastuzumab mono therapy for 9 cycles:

    Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle

Study groups in NCT01472029
Study groupRoleWhat they receive
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumabExperimentalNot described
Receives: Drug: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab; Drug: Post-operative treatment trastuzumab mono therapy

What is being measured

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

  1. Rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist.

    The experimental therapy would be rated as insufficiently active, if the observed pCR rate is 10 % or lower, as this corresponds to the expectations after chemotherapy alone.

    The experimental therapy would be considered to be a promising candidate for further development (e.g. in a phase III trial), if the true pCR rate amounted to 20% or more.

    Measured: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.

Secondary outcomes (3)

  1. R0 resection rate

    The R0 rate is defined as the number of patients with negative surgical margins and no tumor left macroscopically, divided by the total number of recruited eligible patients.

    Measured: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.

  2. Relapse-free survival

    Relapse-free survival (RFS) will be defined as the time from enrolment to the time of disease progression or relapse or death, or to the date of last tumor assessment without any such event (censored observation)

    Measured: From enrollment to end of follow up assessed up to 58 months

  3. Overall survival

    The duration of overall survival (OS) will be determined by measuring the time interval from enrolment to the date of death or last observation, including survival rates after 1, 2 and 3 years.

    Measured: From enrollment to end of follow up assessed up to 58 months.

Timeline

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

  1. First posted16 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completion25 Aug 2014
  4. Study completion12 Sep 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472029
Sponsor's protocol ID
AIO-STO-0310
Other IDs
2011-001507-13
Acronym
HerFLOT
Status last verified
Jun 2017
First submitted
24 Oct 2011
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Hofheinz RD, Hegewisch-Becker S, Kunzmann V, Thuss-Patience P, Fuchs M, Homann N, Graeven U, Schulte N, Merx K, Pohl M, Held S, Keller R, Tannapfel A, Al-Batran SE. Trastuzumab in combination with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel as perioperative treatment for patients with human epidermal growth factor receptor 2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the Arbeitsgemeinschaft Internistische Onkologie Gastric Cancer Study Group. Int J Cancer. 2021 Sep 15;149(6):1322-1331. doi: 10.1002/ijc.33696. Epub 2021 May 29.

    PubMed 34019698

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab and Post-operative treatment trastuzumab mono therapy in people with Adenocarcinoma of the Gastroesophageal Junction and Adenocarcinoma of the Stomach, run by AIO-Studien-gGmbH at 1 site 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 10 inclusion and 14 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 19 Jun 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 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 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?

Rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist. (time frame: From enrollment to surgery after pre-operative treatment (4 cycles = 8 weeks) for 9 weeks.). 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 NCT01472029, 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 19 Jun 2017.

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