Stomach CancerPhase 2/3PETRARCANCT02581462
FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of HER-2 Expressing Gastric or GEJ Cancer
A Phase 2/3 study testing FLOT alone and FLOT + Herceptin/Pertuzumab in people with Stomach Cancer and Gastroesophageal Junction Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 1 site in Germany.
Trial summary
Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or GEJ. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stomach Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- FLOT alone and FLOT + Herceptin/Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to 17 Jul 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the GEJ (type I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications:
- Medical and technical operability
- Centralized detection of either an adenocarcinoma with HER-2 3+ (IHC) or HER-2 2+ (IHC) with amplification proven by FISH, SISH or CISH
- No preceding cytotoxic or targeted therapy
- No prior partial or complete tumor resection
- Exclusion of the infiltration of any adjacent organs or structures by CT or MRI
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- Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and bone scan (if osseous lesions are suspected due to clinical signs)
- Female and male patients ≥ 18 years. Patients in reproductive age must be willing to use adequate contraception during the study and for 7 months after the end of pertuzumab and Herceptin treatment (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.
- ECOG ≤ 2
- Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically
- Adequate haematological, hepatic and renal function parameters:
- Leukocytes ≥ 3.000/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
- LVEF value > 55 %, as assessed by echocardiography
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Who cannot join
- Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastasis!)
- Known hypersensitivity against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Other known contraindications against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Documented history of congestive heart failure of any NYHA, myocardial infarction within the past 6 months before the first dose of study treatment
- Clinically significant valvular defect , history of poorly controlled arterial hypertension (systolic blood pressure > 180 mmHG or diastolic blood pressure > 100 mmHg) or uncontrollable high-risk cardiac arrhythmia (i.e tachycardia with a heart rate > 100/min at rest), significant ventricular arrhythmia (ventricular tachycardia) or higher grade atrioventricular-block (second degree AV-block Type 2 (Mobitz2) or third degree AV-block)
- 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
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- Known brain metastases
- Other severe internal disease or acute infection
- Peripheral polyneuropathy ≥ NCI Grade II
- Chronic inflammatory bowel disease
- Clinically significant active GI bleeding
- 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
Institute for Clinical Cancer Research Krankenhaus Nordwest
Frankfurt, 60488
About this study
Official title: FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of Adenocarcinoma of the Stomach and Gastroesophageal Junction Expressing HER-2. A Phase II/III Trial of the AIO.
Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or GEJ.
Read the detailed description
This is a multicenter, randomized, controlled, open-label study including patients with locally advanced adenocarcinoma of the stomach and GEJ scheduled to receive perioperative chemotherapy. According to centrally assessed HER-2 status: Patients with HER-2 positive tumors will receive FLOT +/- Herceptin / pertuzumab.
The scope of the phase II portion of the trial is to evaluate pathological response rates of either regimen assessed by a centralized pathology and define safety and tolerability.
Patients with locally advanced esophagogastric adenocarcinoma (i.e. cT2 any N or any T N-positive) with exclusion of distant metastases will be included in this trial.
Patients will be stratified by age (18-69 vs. ≥ 70), tumor site (GEJ vs. gastric) and clinical stage (T1/2 vs. 3/4 and N- vs. N+) and randomized 1:1 to receive either FLOT (Arm A) or FLOT/Herceptin/pertuzumab (Arm B).
Arm A (control group) Patients randomized to Arm A will receive 4 pre-operative treatments of FLOT (Docetaxel 50 mg/m², iv over 2 h; Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h; Leucovorin 200 mg/m² in 250 ml NaCl 0.9 %, iv over 1 h; 5-FU 2600 mg/m², iv over 24 h) on d1, d15, d29, d43 of the preoperative treatment phase. Surgery is recommended to occur 4 weeks after last FLOT (4 weeks after d43 = day 71). Patients will receive 4 additional post-operative treatments of FLOT on d1, d15, d29, and d43 of the post-operative treatment phase. Post-operative treatment should start 6 to 8 weeks, but at maximum 12 weeks after surgery.
Arm B (Herceptin/pertuzumab group) Patients randomized to Arm B will receive the FLOT regimen identical to Arm A as described above in conjunction with three-weekly Herceptin at 8mg/kg initial dose (Day 1, loading dose) followed by subsequent doses of Herceptin at 6mg/kg on d22 and d43 and pertuzumab at 840mg on d1, d22, and d43. Surgery is recommended to occur 4 weeks after last FLOT/Herceptin/pertuzumab dose (4 weeks after d43 = day 71). Patients will receive 3 additional doses of Herceptin and pertuzumab on d1, d22, and d43 of the post-operative treatment phase, together with the postoperative chemotherapy. Moreover, patients will receive 11 additional doses of Herceptin and pertuzumab after the end of post-operative FLOT.
In both of the arms, tumor assessments (CT or MRI) are performed before randomization and prior to surgery and then every 3 months thereafter until progression/relapse, death or end of follow-up.
During treatment, clinical visits (blood cell counts, detection of toxicity) occur prior to every treatment dose. Safety of FLOT/Herceptin/pertuzumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported.
- Conditions
- Stomach Cancer, Gastroesophageal Junction Cancer
- Being tested
- FLOT alone, FLOT + Herceptin/Pertuzumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOT aloneDrug
Pre-operative therapy:
- Docetaxel 50 mg/m², d1, d15, d29, d43
- Oxaliplatin 85 mg/m², d1, d15, d29, d43
- Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
- 5-FU 2600 mg/m², d1, d15, d29, d43
Surgery is recommended to be scheduled 4 weeks after d43.
Post-operative therapy (start 6 to 8 weeks after surgery):
- Docetaxel 50 mg/m², d1, d15, d29, d43
- Oxaliplatin 85 mg/m², d1, d15, d29, d43
- Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
- 5-FU 2600 mg/m², d1, d15, d29, d43
FLOT + Herceptin/PertuzumabBiological
Pre-operative therapy:
- Herceptin 8/6 mg/kg, d1, d22, d43
- Pertuzumab 840 mg, d1, d22, d43
- Docetaxel 50 mg/m², d1, d15, d29, d43
- Oxaliplatin 85 mg/m², d1, d15, d29, d43
- Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
- 5-FU 2600 mg/m², d1, d15, d29, d43
Surgery is recommended to be scheduled 4 weeks after d43.
Post-operative therapy (start 6 to 8 weeks after surgery):
- Herceptin 8/6 mg/kg, d1, d22, d43
- Pertuzumab 840 mg, d1, d22, d43
- Docetaxel 50 mg/m², d1, d15, d29, d43
- Oxaliplatin 85 mg/m², d1, d15, d29, d43
- Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
- 5-FU 2600 mg/m², d1, d15, d29, d43.
| Study group | Role | What they receive |
|---|---|---|
| FLOT alone | Experimental | Pre-operative therapy with FLOT followed by surgical resection followed by post-operative therapy with FLOT Receives: Drug: FLOT alone |
| FLOT + Herceptin/Pertuzumab | Experimental | Pre-operative therapy with FLOT + Herceptin/Pertuzumab followed by surgical resection followed by post-operative therapy with FLOT + Herceptin/Pertuzumab Receives: Biological: FLOT + Herceptin/Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PhaseII: Rate of pathological complete response
Measured: 3 years
Phase III: Median Progression Free Survival
Measured: 5 years
Secondary outcomes (11)
Phase II/III: R0 resection rate
Measured: 75 days
Phase II: Median Progression Free Survival (PFS)
Measured: 3 years
Phase II/III: Median Overall Survival
Measured: 3/5 years
Phase II: PK Analysis
Measured: 3 years
Phase II/III: Subgroup analyses: pathological response according to HER-2 status HER-2 IHC 3+ vs. other cases
Measured: 3/5 years
Phase II/III: Subgroup analyses: PFS according to HER-2 status HER-2 IHC 3+ vs. other cases
Measured: 3/5 years
Phase II/III: Subgroup analyses: OS according to HER-2 status HER-2 IHC 3+ vs. other cases
Measured: 3/5 years
Phase III: Pathological Response Rates
Measured: 5 years
Phase III: PFS rates
Measured: 3 and 5 years
Phase III: OS rates
Measured: 3 and 5 years
Phase III: Median OS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJun 2016
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Trium Analysis Online GmbH
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr., Study chair, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581462
- Sponsor's protocol ID
- ML29452/PETRARCA/FLOT6
- Acronym
- PETRARCA
- Status last verified
- Aug 2020
- First submitted
- 19 Oct 2015
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD will be shared.
Publications
Hofheinz RD, Merx K, Haag GM, Springfeld C, Ettrich T, Borchert K, Kretzschmar A, Teschendorf C, Siegler G, Ebert MP, Goekkurt E, Mahlberg R, Homann N, Pink D, Bechstein W, Reichardt P, Flach H, Gaiser T, Battmann A, Oduncu FS, Loose M, Sookthai D, Pauligk C, Goetze TO, Al-Batran SE. FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy of Human Epidermal Growth Factor Receptor 2-Positive Resectable Esophagogastric Adenocarcinoma: A Randomized Phase II Trial of the AIO EGA Study Group. J Clin Oncol. 2022 Nov 10;40(32):3750-3761. doi: 10.1200/JCO.22.00380. Epub 2022 Jun 16.
PubMed 35709415
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of Adenocarcinoma of the Stomach and Gastroesophageal Junction Expressing HER-2. A Phase II/III Trial of the AIO.
- ClinicalTrials.gov ID
- NCT02581462
- Acronym / sponsor ID
- PETRARCA / ML29452/PETRARCA/FLOT6
- Conditions
- Stomach Cancer, Gastroesophageal Junction Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Trium Analysis Online GmbH
- Study start
- Jun 2016 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or GEJ.
Detailed description
This is a multicenter, randomized, controlled, open-label study including patients with locally advanced adenocarcinoma of the stomach and GEJ scheduled to receive perioperative chemotherapy. According to centrally assessed HER-2 status: Patients with HER-2 positive tumors will receive FLOT +/- Herceptin / pertuzumab.
The scope of the phase II portion of the trial is to evaluate pathological response rates of either regimen assessed by a centralized pathology and define safety and tolerability.
Patients with locally advanced esophagogastric adenocarcinoma (i.e. cT2 any N or any T N-positive) with exclusion of distant metastases will be included in this trial.
Patients will be stratified by age (18-69 vs. ≥ 70), tumor site (GEJ vs. gastric) and clinical stage (T1/2 vs. 3/4 and N- vs. N+) and randomized 1:1 to receive either FLOT (Arm A) or FLOT/Herceptin/pertuzumab (Arm B).
Arm A (control group) Patients randomized to Arm A will receive 4 pre-operative treatments of FLOT (Docetaxel 50 mg/m², iv over 2 h; Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h; Leucovorin 200 mg/m² in 250 ml NaCl 0.9 %, iv over 1 h; 5-FU 2600 mg/m², iv over 24 h) on d1, d15, d29, d43 of the preoperative treatment phase. Surgery is recommended to occur 4 weeks after last FLOT (4 weeks after d43 = day 71). Patients will receive 4 additional post-operative treatments of FLOT on d1, d15, d29, and d43 of the post-operative treatment phase. Post-operative treatment should start 6 to 8 weeks, but at maximum 12 weeks after surgery.
Arm B (Herceptin/pertuzumab group) Patients randomized to Arm B will receive the FLOT regimen identical to Arm A as described above in conjunction with three-weekly Herceptin at 8mg/kg initial dose (Day 1, loading dose) followed by subsequent doses of Herceptin at 6mg/kg on d22 and d43 and pertuzumab at 840mg on d1, d22, and d43. Surgery is recommended to occur 4 weeks after last FLOT/Herceptin/pertuzumab dose (4 weeks after d43 = day 71). Patients will receive 3 additional doses of Herceptin and pertuzumab on d1, d22, and d43 of the post-operative treatment phase, together with the postoperative chemotherapy. Moreover, patients will receive 11 additional doses of Herceptin and pertuzumab after the end of post-operative FLOT.
In both of the arms, tumor assessments (CT or MRI) are performed before randomization and prior to surgery and then every 3 months thereafter until progression/relapse, death or end of follow-up.
During treatment, clinical visits (blood cell counts, detection of toxicity) occur prior to every treatment dose. Safety of FLOT/Herceptin/pertuzumab will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLOT alone | Experimental | Drug: FLOT alonePre-operative therapy with FLOT followed by surgical resection followed by post-operative therapy with FLOT |
| FLOT + Herceptin/Pertuzumab | Experimental | Biological: FLOT + Herceptin/PertuzumabPre-operative therapy with FLOT + Herceptin/Pertuzumab followed by surgical resection followed by post-operative therapy with FLOT + Herceptin/Pertuzumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed adenocarcinoma of the GEJ (type I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications:
- No preceding cytotoxic or targeted therapy
- No prior partial or complete tumor resection
- Exclusion of the infiltration of any adjacent organs or structures by CT or MRI
- Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and bone scan (if osseous lesions are suspected due to clinical signs)
Key exclusion criteria (15 listed)
- Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastasis!)
- Known hypersensitivity against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Other known contraindications against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Documented history of congestive heart failure of any NYHA, myocardial infarction within the past 6 months before the first dose of study treatment
- Clinically significant valvular defect , history of poorly controlled arterial hypertension (systolic blood pressure > 180 mmHG or diastolic blood pressure > 100 mmHg) or uncontrollable high-risk cardiac arrhythmia (i.e tachycardia with a heart rate > 100/min at rest), significant ventricular arrhythmia (ventricular tachycardia) or higher grade atrioventricular-block (second degree AV-block Type 2 (Mobitz2) or third degree AV-block)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOT alonePre-operative therapy: * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43 Surgery is recommended to be scheduled 4 weeks after d43. Post-operative therapy (start 6 to 8 weeks after surgery): * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43 | Drug | FLOT alone |
| FLOT + Herceptin/PertuzumabPre-operative therapy: * Herceptin 8/6 mg/kg, d1, d22, d43 * Pertuzumab 840 mg, d1, d22, d43 * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43 Surgery is recommended to be scheduled 4 weeks after d43. Post-operative therapy (start 6 to 8 weeks after surgery): * Herceptin 8/6 mg/kg, d1, d22, d43 * Pertuzumab 840 mg, d1, d22, d43 * Docetaxel 50 mg/m², d1, d15, d29, d43 * Oxaliplatin 85 mg/m², d1, d15, d29, d43 * Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines) * 5-FU 2600 mg/m², d1, d15, d29, d43. | Biological | FLOT + Herceptin/Pertuzumab |
Primary outcome
PhaseII: Rate of pathological complete response
Time frame: 3 years
Phase III: Median Progression Free Survival
Time frame: 5 years
11 secondary outcomes
Phase II/III: R0 resection rate
Time frame: 75 days
Phase II: Median Progression Free Survival (PFS)
Time frame: 3 years
Phase II/III: Median Overall Survival
Time frame: 3/5 years
Phase II: PK Analysis
Time frame: 3 years
Phase II/III: Subgroup analyses: pathological response according to HER-2 status HER-2 IHC 3+ vs. other cases
Time frame: 3/5 years
Phase II/III: Subgroup analyses: PFS according to HER-2 status HER-2 IHC 3+ vs. other cases
Time frame: 3/5 years
Phase II/III: Subgroup analyses: OS according to HER-2 status HER-2 IHC 3+ vs. other cases
Time frame: 3/5 years
Phase III: Pathological Response Rates
Time frame: 5 years
Phase III: PFS rates
Time frame: 3 and 5 years
Phase III: OS rates
Time frame: 3 and 5 years
Phase III: Median OS
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 35709415Hofheinz RD, Merx K, Haag GM, Springfeld C, Ettrich T, Borchert K, Kretzschmar A, Teschendorf C, Siegler G, Ebert MP, Goekkurt E, Mahlberg R, Homann N, Pink D, Bechstein W, Reichardt P, Flach H, Gaiser T, Battmann A, Oduncu FS, Loose M, Sookthai D, Pauligk C, Goetze TO, Al-Batran SE. FLOT Versus FLOT/Trastuzumab/Pertuzumab Perioperative Therapy of Human Epidermal Growth Factor Receptor 2-Positive Resectable Esophagogastric Adenocarcinoma: A Randomized Phase II Trial of the AIO EGA Study Group. J Clin Oncol. 2022 Nov 10;40(32):3750-3761. doi: 10.1200/JCO.22.00380. Epub 2022 Jun 16.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah-Eddin Al-Batran, Prof. Dr. study chair
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FLOT alone and FLOT + Herceptin/Pertuzumab in people with Stomach Cancer and Gastroesophageal Junction Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest 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 16 inclusion and 15 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 11 Aug 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 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 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?
PhaseII: Rate of pathological complete response (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02581462, 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 11 Aug 2020.