Surgery as needed versus surgery on principle in patients with postneoadjuvant clinical complete tumor response of esophageal cancer
Organizational Data
- DRKS-ID:
- DRKS00032613
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-09-27
- Last update in DRKS:
- 2024-02-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
ESORES-Trial
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
To investigate differences in outcomes in patients treated with active surveillance and surgery as needed only in persisting or recurring locoregional tumor versus surgery on principle. The primary hypothesis is that the overall survival in a protocol with clinical identification and active surveillance of complete response (CR) with surgery only as needed is non-inferior compared to surgery on principle. It is hypothesized that active surveillance of CR with surgery as needed is superior with regard to health related quality of life of the patients.
Health condition or problem studied
- ICD10:
- C15 - Malignant neoplasm of oesophagus
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Experimental intervention: Arm A consists of clinical response evaluation (CRE) including esophagogastroscopy, endoscopic deep biopsies of the tumor area, endoscopic ultrasound (EUS) plus fine needle aspiration (FNA) of suspicious lymph nodes, pathology workup of biopsies and FNA aspirates and F18-FDG-PET CT. CRE is done 10 weeks after completion of neoadjuvant treatment. In case of clinical histology-proven positive local tumor status and without distant metastasis after CRE („non-CR“), treatment is surgery. Patients without histologic evidence of local residual disease and without distant metastasis will be considered as clinical CR and will directly proceed with consecutive surveillance with surgery only in the event of a local tumor recurrence. Active surveillance is done by visits 3m/6m/9m/12m/18m/24m/36m after randomization and comprises esophagogastroscopy, endoscopic deep biopsies of the tumor area, EUS plus FNA of suspicious lymph nodes, pathology workup of biopsies and FNA aspirates and CT Thorax/Abdomen. In case of histology-proven diagnosis of recurring tumor during active surveillance („non-CR“), surgery and subsequent standard follow-up is done. In patients with a high diagnostic suspicion of tumor regrowth despite negative histology in CRE or active surveillance visits a trial multidisciplinary tumor board will review the case and decide if surgery should be recommended or active surveillance can go on.
- Arm 2:
- Control intervention: Arm B consists of postneoadjuvant surgery on principle performed 4-12 weeks after end of neoadjuvant treatment. In both arms, surgery is carried out by open or minimally-invasive esophagectomy including loco-regional lymphadenectomy. Pre-therapeutically scheduled adjuvant cycles of perioperative chemotherapy protocols are not affected by the trial. They can be given either post-surgery in patients in arm B and non-CR patients in arm A or post-CRE in CR-patients in arm A as a part of the regular non-trial treatment.
Endpoints
- Primary outcome:
- Primary endpoints (hierachically tested): a) Overall survival (OS) time. b) EORTC QLQ C30 global quality of life subscale.
- Secondary outcome:
- Secondary endpoints: Efficacy: • long term tumor control: o disease free survival (DFS) time, o time to distant metastasis (TDM), o time to local recurrence, o time to regional recurrence. • quality of life: o EORTC QLQ C30, o EORTC QLQ OES18. o fear of progression (FoP-Q-12), o surgery-free survival (SFS) time in arm A, o patients’ satisfaction, • economic impact: o days of hospitalization, o hospitalization costs. Safety: • Interventional Safety: perioperative complications and periinterventional complications summarized by the 3-Year-Comprehensive Complication Index (3-Year-CCI) • Oncological Safety: o diagnostic accuracy of CRE in arm A o resection status (R0/R1/R2) o irresectable regrowth during active surveillance in arm A
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinik Schleswig-Holstein, Campus Lübeck 01-Lübeck
- University medical center Universitätsklinik Freiburg 02-Freiburg
- Medical center Klinikum Dortmund gGmbH 08-Dortmund
- University medical center Charité - Universitätsmedizin Berlin-CBF 12-Berlin
- University medical center Universitätsklinikum Münster (UKM) 09 - Münster
Recruitment period and number of participants
- Planned study start date:
- 2023-12-31
- Actual study start date:
- 2024-01-30
- Planned study completion date:
- 2027-10-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 670
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Key inclusion criteria: • EC (adenocarcinoma (EAC) and squamous cell carcinoma (ESCC)) according to the UICC definition (TNM8), • TNM stage: ycT0-3 ycN0 ycM0, • completion of neoadjuvant chemotherapy or neoadjuvant chemoradiation • no visible lymphatic or distant metastasis in routine postneoadjuvant CT, • ECOG Performance status 0-2 • Age ≥ 18 years
Exclusion Criteria
Key exclusion criteria: • Postneoadjuvant dysphagia • Tumors of the cervical esophagus • Tumors with direct proximity to the membranous part of the central airway • TNM stage cT4 or ycT4 • TNM stage cM1 or ycM1 • Postneoadjuvant esophageal obstruction • Local tumor progression during/after neoadjuvant therapy detected by endoscopy or cross-sectional imaging • Time since last day of neoadjuvant anti-cancer treatment ≥ 9 weeks • Co-morbidity with contraindication for major surgery • nCRT with >50 Gy radiation dose
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck23538 LübeckGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Schleswig-Holstein, Campus LübeckProf. Dr. med. Jens HöppnerRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0049 451 500-40101
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Schleswig-Holstein, Campus LübeckProf. Dr. med. Jens HöppnerRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0049 451 500-40101
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Schleswig-Holstein, Campus LübeckProf. Dr. med. Jens HöppnerRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0049 451 500-40101
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- BMBF53175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-31011026
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-luebeck.de/forschung/kommissionen/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-06-30
- Ethics committee number:
- 2023-533
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-09-06
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072500
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/ethikkommission.html
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-11-14
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-NürnbergKrankenhausstr. 1291054 ErlangenGermany
- Telephone:
- +40-9131-8522270
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ethikkommission.fau.de
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2023-10-16
Other Address Ethics Committee
- Address:
- Ethik-Kommission Westfalen-LippeGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ethik-kommission-wl.de/
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-10-28
Other Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umg.eu/ueber-uns/vorstand/kommissionen/ethikkommission/
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-11-21
Other Address Ethics Committee
- Address:
- Ethikkommission der Technischen Universität MünchenIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- +49-89-41407737
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ek-med-muenchen.de/index.php?lang=de
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-11-23
Other Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin, Universitätsklinikum der Goethe-UniversitätTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63013758
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de/ueber-uns/vorstand-des-universitaetsklinikums/dekan/ethikkommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-11-16
Other Address Ethics Committee
- Address:
- Medizinische Fakultät der Christian-Albrechts-Universität zu KielArnold-Heller-Straße 3 / Haus U2724105 KielGermany
- Telephone:
- +49 431 500 14 191
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-kiel.de/de/fakultaet/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-14
Other Address Ethics Committee
- Address:
- Ethikkommission der Landesärztekammer BrandenburgDreifertstr. 1203044 CottbusGermany
- Telephone:
- +49-355-78010151/-152
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://laekb.de/www/website/PublicNavigation/arzt/ethikkommission/
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-19
Other Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ethikkommission.charite.de
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- No Entry
Other Address Ethics Committee
- Address:
- Medizinische Ethikkommission an der Julius-Maximilians-Universität WürzburgJosef-Schneider-Str. 4, C1597080 WürzburgGermany
- Telephone:
- +49 931 31 48315
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-wuerzburg.de/ethik-kommission/startseite
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-02-08
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-202299240
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aerztekammer-hamburg.org/ethikkommission.html
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-02-05
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer BerlinFriedrichstraße 1610696 BerlinGermany
- Telephone:
- (+49)30-408062601
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aekb.de/kammer/kommissionen/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- No Entry
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Bayerischen LandesärztekammerMühlbaurstr. 1681677 MünchenGermany
- Telephone:
- +49-89-4147165
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ethikkommission.blaek.de
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- No Entry
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- 01KD2205A - BMBF
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00022050 - Surgery as needed versus surgery on principle in patients with post-neoadjuvant complete response of esophageal cancer (ESORES) - PILOT STUDY on Patient Participation
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry