Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus (ESOPEC)
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| ClinicalTrials.gov Identifier: NCT02509286 |
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Recruitment Status :
Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : November 4, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Adenocarcinoma (UICC TNM7) Adenocarcinoma of the Esophagogastric Junction | Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Docetaxel Drug: Carboplatin Drug: Paclitaxel Radiation: Neoadjuvant radiation | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 438 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus |
| Study Start Date : | January 2016 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | June 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Perioperative Chemotherapy (FLOT):
The 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. |
Drug: 5-Fluorouracil
2600 mg/m² (24 hours), d1 every two weeks; Drug: Leucovorin 200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks; Drug: Oxaliplatin 85 mg/m² in 500 ml G5% over 2h, d1 every two weeks; Drug: Docetaxel 50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks; |
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Active Comparator: Neoadjuvant Chemoradiation (CROSS):
The 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. |
Drug: Carboplatin
Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29. Drug: Paclitaxel 50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29; Radiation: Neoadjuvant radiation 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. |
- Overall survival [ Time Frame: At end of trial- up to 3 years in follow up ]Overall survival will be calculated as time from start of study treatment to death due to any cause.
- Progression free survival time (PFS) [ Time Frame: From randomisation up to 3 years in follow up ]PFS will be calculated as the time interval from randomisation to the first event of locoregional failure, metastatic progression or death.
- Site of failure: local, regional or distant Failure [ Time Frame: From time of surgery up to 3 years in follow up ]
- Recurrence free survival time [ Time Frame: From time of surgery up to 3 years in follow up ]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.
- Postsurgical Quality of Life [ Time Frame: From randomization up to 3 years in follow up ]
- Postoperative complications [ Time Frame: From time of surgery up to 90 days postoperatively ]
- Non-surgical site complications [ Time Frame: From time of surgery up to 90 days postoperatively ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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)
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509286
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| Principal Investigator: | Jens Hoeppner, Professor | University Medical Center Schleswig-Holstein, Campus Lübeck |
Publications:
| Responsible Party: | Jens Hoeppner, Deputy Director - Department of Surgery, University Hospital Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT02509286 |
| Other Study ID Numbers: |
P000760 2015-001683-20 ( EudraCT Number ) DRKS00008008 ( Registry Identifier: DRKS ) |
| First Posted: | July 28, 2015 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | November 2022 |
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Esophageal neoplasms gastro-esophageal junction neoplasms adenocarcinoma esophagectomy |
surgery radiotherapy chemotherapy |
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Leucovorin Paclitaxel Docetaxel Carboplatin Fluorouracil Oxaliplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients |