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Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cetuximab
cisplatin
docetaxel
adjuvant therapy
neoadjuvant therapy
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring stage IIB esophageal cancer, adenocarcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, squamous cell carcinoma of the esophagus, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed esophageal carcinoma

  • Meets the following criteria:

    • Resectable, locally advanced disease as determined by the combination of CT scan, endoluminal ultrasound (EUS), PET scan, and a multidisciplinary team discussion

      • T2, N1-3; T3, any N; or T4a, any N (if technically resectable with curative intent [R0] as decided by a multidisciplinary team discussion)

        • EUS-guided fine-needle aspiration (FNA) allowed, but determines nodal status only if positive FNA
      • No T1, any N, M0; or T2, N0, M0; T4a (due to infiltration of the trachea-bronchial tree or organ involvement that cannot be operated on with curative intent [R0] as decided by a multidisciplinary team discussion); T4b; or distant metastasis (M1)
    • Type I or II disease according to the Siewert classification
    • Squamous cell carcinoma (including basaloid-squamous cell and adenosquamous carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric junction (from 5 cm below the entrance of the esophagus into the thorax to the gastric cardia)
  • Patients with obstructive tumors are eligible (obstructive tumors will be considered as locally advanced tumors)
  • No cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic esophagus
  • No airway infiltration in case of tumors at or above the tracheal bifurcation
  • No peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric cardia (i.e., esophagogastric junction carcinoma Siewert type I or II)

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Creatinine clearance > 60 mL/min
  • Bilirubin ≤ 1.0 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 1.5 times ULN
  • INR normal
  • PTT ≤ 1.0 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • FEV_1 ≥ 1.5 L OR ≥ 75% of the reference value
  • Must be compliant and geographically proximal for staging and follow-up
  • Considered operable (i.e., appropriate organ functions and ability to undergo general anesthesia)
  • No other malignancies within the past 5 years except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix

  • No severe or uncontrolled cardiovascular disease, including any of the following:

    • NYHA class III-IV congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 12 months
    • Significant arrhythmias
  • No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, and answering questionnaires
  • No active uncontrolled infection
  • No serious underlying medical condition that, in the opinion of the investigator, could impair the ability of the patient to participate in the trial (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
  • No preexisting peripheral neuropathy > grade 1
  • No definite contraindications for the use of corticosteroids and antihistamines as premedication
  • No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy to the chest
  • At least 30 days since prior treatment in another clinical trial
  • No concurrent drugs contraindicated for use with the trial drugs
  • No other concurrent anticancer treatments
  • No other concurrent experimental drugs or investigational treatments

Sites / Locations

  • Landeskrankenhaus
  • Universitätsklinik für Innere Medizin I
  • Krankenhaus Barmherzige Schwestern Linz
  • Krankenhaus der Elisabethinen Linz GmbH
  • Universitätsklinikum der PMU Salzburg
  • Klinikum Wels-Grieskirchen GmbH
  • Universitätsklinik für Innere Medizin
  • Hôpital Avicenne
  • Centre Hospitalier Général
  • Hôtel Dieu Estaing
  • CHU Le Bocage
  • Centre Georges-François Leclerc
  • Centre Bourgogne
  • CHRU de Lille
  • Clinique François Chénieux
  • CHU la TIMONE
  • CH Régional de la Source
  • CH Saint Jean
  • Hôpital Haut Leveque
  • CHU
  • CHU de Saint Etienne - Hôpital Nord
  • Clinique Ste Anne
  • Hôpital Purpan
  • Charite University Hospital - Campus Virchow Klinikum
  • Universitaetsklinikum Duesseldorf
  • Kliniken Essen - Mitte
  • Universitaetsklinikum Freiburg
  • SLK-Kliniken Heilbronn GmbH
  • Klinikum Herford
  • Klinikum Ludwigsburg
  • Universitaetsklinikum Giessen und Marburg GmbH
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Staedtisches Klinikum Solingen
  • Klinikum Stuttgart - Katharinenhospital
  • Universitaetsklinikum Tuebingen
  • Szent Laszlo Korhaz
  • Hirslanden Klinik Aarau
  • Kantonsspital Aarau
  • Kantonsspital Baden
  • St. Claraspital AG
  • Universitaetsspital-Basel
  • Inselspital Bern
  • Kantonsspital Bruderholz
  • Kantonsspital Graubuenden
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital Liestal
  • Kantonsspital Olten
  • Hôpital du Valais (RSV)-CHCVs
  • Kantonsspital - St. Gallen
  • Regionalspital
  • Ospedale Italiano
  • Kantonsspital Winterthur
  • Onkozentrum Klinik im Park
  • Klinik Hirslanden
  • City Hospital Triemli
  • UniversitaetsSpital Zuerich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Additional immunotherapy (cetuximab)

Without additional immunotherapy

Arm Description

All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.

Standard therapy without immunotherapy (cetuximab).

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
time from randomization to one of the following events, whichever comes first: Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) Recurrence at local, regional or distant site after surgery Death from any cause

Secondary Outcome Measures

Progression-free survival after surgery
Adverse events according to CTCAE version 4.0 and major postoperative complications
Pathological remission
Overall survival
Time to locoregional failure after R0 resection
Time to systemic failure after R0 resection
In-hospital mortality
Time to progression (TTP)

Full Information

First Posted
April 20, 2010
Last Updated
October 19, 2020
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT01107639
Brief Title
Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
Official Title
Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 27, 2010 (Actual)
Primary Completion Date
October 6, 2016 (Actual)
Study Completion Date
December 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer. PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
Detailed Description
OBJECTIVES: Primary To determine the efficacy of neoadjuvant radiochemotherapy comprising docetaxel, cisplatin, and radiotherapy in combination with cetuximab followed by surgery and adjuvant cetuximab versus neoadjuvant radiochemotherapy comprising docetaxel, cisplatin, and radiotherapy followed by surgery in patients with locally advanced esophageal carcinoma. Secondary To compare the toxicity of the two therapy arms. To determine patterns of failure overall and with regard to histology. To evaluate economic aspects in a subproject and to perform a radiotherapy quality assurance program. OUTLINE: This is a multicenter study. Patients are stratified according to center, histology (adenocarcinoma vs squamous cell carcinoma), primary tumor (T2 vs T3-4), and gender (male vs female). Patients are randomized to 1 of 2 treatment arms. Arm A: Induction chemotherapy (docetaxel and cisplatin) and concurrent cetuximab Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and cetuximab IV over 1-2 hours on day 1, 8, and 15. Treatment repeats every 21 days for 2 courses. Chemotherapy (docetaxel and cisplatin), cetuximab, and concurrent radiotherapy Beginning in week 7, patients receive cetuximab IV over 1 hour, docetaxel IV over 30 minutes, cisplatin IV over 1 hour on days 43, 50, 57, 64, and 71 and undergo radiotherapy 5 days a week for 5 weeks. Patients then undergo surgery 4-7 weeks after completion of radiotherapy. Adjuvant cetuximab Beginning 3-6 weeks after completion of surgery, patients receive cetuximab IV over 1-2 hours once every 2 weeks for a total of 6 doses. Arm B: Patients receive induction chemotherapy comprising docetaxel IV and cisplatin IV for 2 courses as in arm A. Beginning in week 7, patients receive docetaxel IV, cisplatin IV, and concurrent radiotherapy for 5 weeks as in arm A. Patients then undergo surgery 4-7 weeks after completion of radiotherapy. After completion of study therapy, patients are followed up at 1 (arm B) or 6 (arm A) months, every 3 months for 3 years, and then every 6 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer
Keywords
stage IIB esophageal cancer, adenocarcinoma of the esophagus, adenocarcinoma of the gastroesophageal junction, squamous cell carcinoma of the esophagus, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Additional immunotherapy (cetuximab)
Arm Type
Experimental
Arm Description
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
Arm Title
Without additional immunotherapy
Arm Type
Active Comparator
Arm Description
Standard therapy without immunotherapy (cetuximab).
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Loading dose 400 mg/m2 2h infusion Weekly: 250 mg/m2 1h infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin 75 mg/m2 1h infusion d1, 22 Cisplatin 25 mg/m2 1h infusion weekly x5
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere or generic product
Intervention Description
Docetaxel 75 mg/m2 1h infusion d1, 22 Docetaxel 20 mg/m2 1/2h infusion weekly x5
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Description
During the adjuvant phase, all infusions, given every two weeks, will be at a dose of 500mg/m².
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Description
During the neoadjuvant phase, the first infusion of cetuximab should be at a dose of 400 mg/m² administered over a period of 2 hours and all subsequent infusions, given weekly, should be of 250 mg/m² over a period of 1 hour, unless any infusion related reaction was observed at a previous infusion. (The maximum infusion rate is 10 mg/min, corresponding to 2 mL/min ready-to-use solution.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
time from randomization to one of the following events, whichever comes first: Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) Recurrence at local, regional or distant site after surgery Death from any cause
Time Frame
time from randomization to a defined event.
Secondary Outcome Measure Information:
Title
Progression-free survival after surgery
Time Frame
from date of surgery to an event as defined in PFS.
Title
Adverse events according to CTCAE version 4.0 and major postoperative complications
Time Frame
during treatment and follow-up period.
Title
Pathological remission
Time Frame
Assessed according to the tumor regression model of Mandard
Title
Overall survival
Time Frame
time from trial randomization to the date of death from any cause
Title
Time to locoregional failure after R0 resection
Time Frame
from date of surgery to date of first documented loco-regional failure
Title
Time to systemic failure after R0 resection
Time Frame
from date of surgery to date of first documented systemic failure
Title
In-hospital mortality
Time Frame
occurring after surgery but while the patient remains in hospital
Title
Time to progression (TTP)
Time Frame
Time to progression is defined as time from randomization to one of the following events, whichever comes first: - Tumor progression at any time. - Recurrence at local, regional or distant site after surgery. - Death due to tumor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal carcinoma Meets the following criteria: Resectable, locally advanced disease as determined by the combination of CT scan, endoluminal ultrasound (EUS), PET scan, and a multidisciplinary team discussion T2, N1-3; T3, any N; or T4a, any N (if technically resectable with curative intent [R0] as decided by a multidisciplinary team discussion) EUS-guided fine-needle aspiration (FNA) allowed, but determines nodal status only if positive FNA No T1, any N, M0; or T2, N0, M0; T4a (due to infiltration of the trachea-bronchial tree or organ involvement that cannot be operated on with curative intent [R0] as decided by a multidisciplinary team discussion); T4b; or distant metastasis (M1) Type I or II disease according to the Siewert classification Squamous cell carcinoma (including basaloid-squamous cell and adenosquamous carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric junction (from 5 cm below the entrance of the esophagus into the thorax to the gastric cardia) Patients with obstructive tumors are eligible (obstructive tumors will be considered as locally advanced tumors) No cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic esophagus No airway infiltration in case of tumors at or above the tracheal bifurcation No peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric cardia (i.e., esophagogastric junction carcinoma Siewert type I or II) PATIENT CHARACTERISTICS: WHO performance status 0-1 Neutrophil count ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Creatinine clearance > 60 mL/min Bilirubin ≤ 1.0 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN AST ≤ 1.5 times ULN INR normal PTT ≤ 1.0 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study therapy FEV_1 ≥ 1.5 L OR ≥ 75% of the reference value Must be compliant and geographically proximal for staging and follow-up Considered operable (i.e., appropriate organ functions and ability to undergo general anesthesia) No other malignancies within the past 5 years except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix No severe or uncontrolled cardiovascular disease, including any of the following: NYHA class III-IV congestive heart failure Unstable angina pectoris Myocardial infarction within the past 12 months Significant arrhythmias No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, and answering questionnaires No active uncontrolled infection No serious underlying medical condition that, in the opinion of the investigator, could impair the ability of the patient to participate in the trial (e.g., uncontrolled diabetes mellitus or active autoimmune disease) No preexisting peripheral neuropathy > grade 1 No definite contraindications for the use of corticosteroids and antihistamines as premedication No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy to the chest At least 30 days since prior treatment in another clinical trial No concurrent drugs contraindicated for use with the trial drugs No other concurrent anticancer treatments No other concurrent experimental drugs or investigational treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ruhstaller, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Stahl, MD
Organizational Affiliation
Kliniken Essen-Mitte
Official's Role
Study Chair
Facility Information:
Facility Name
Landeskrankenhaus
City
Feldkirch
ZIP/Postal Code
A-6807
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin I
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Krankenhaus Barmherzige Schwestern Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz GmbH
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Centre Hospitalier Général
City
Béziers
ZIP/Postal Code
34525
Country
France
Facility Name
Hôtel Dieu Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Le Bocage
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Bourgogne
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique François Chénieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
CHU la TIMONE
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CH Régional de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
CH Saint Jean
City
Perpignan Cedex
ZIP/Postal Code
66046
Country
France
Facility Name
Hôpital Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
CHU
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Saint Etienne - Hôpital Nord
City
St Priest En Jarez
ZIP/Postal Code
42277
Country
France
Facility Name
Clinique Ste Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31509
Country
France
Facility Name
Charite University Hospital - Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Kliniken Essen - Mitte
City
Essen
ZIP/Postal Code
D-45136
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Klinikum Herford
City
Herford
ZIP/Postal Code
D-32049
Country
Germany
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
D-71640
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH
City
Marburg
ZIP/Postal Code
D-35043
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Staedtisches Klinikum Solingen
City
Solingen
ZIP/Postal Code
D-42653
Country
Germany
Facility Name
Klinikum Stuttgart - Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Szent Laszlo Korhaz
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Hirslanden Klinik Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
St. Claraspital AG
City
Basel
ZIP/Postal Code
CH-4016
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital Liestal
City
Liestal
ZIP/Postal Code
CH-4410
Country
Switzerland
Facility Name
Kantonsspital Olten
City
Olten
ZIP/Postal Code
CH-4600
Country
Switzerland
Facility Name
Hôpital du Valais (RSV)-CHCVs
City
Sion
ZIP/Postal Code
1951
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Ospedale Italiano
City
Viganello
ZIP/Postal Code
CH-6962
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8400
Country
Switzerland
Facility Name
Onkozentrum Klinik im Park
City
Zurich
ZIP/Postal Code
8038
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
CH-8063
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29635438
Citation
Ruhstaller T, Thuss-Patience P, Hayoz S, Schacher S, Knorrenschild JR, Schnider A, Plasswilm L, Budach W, Eisterer W, Hawle H, Mariette C, Hess V, Mingrone W, Montemurro M, Girschikofsky M, Schmidt SC, Bitzer M, Bedenne L, Brauchli P, Stahl M; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian 'Arbeitsgemeinschaft Medikamentose Tumortherapie' (AGMT); Federation Francophone de Cancerologie Digestive (FFCD)/Federation de Recherche en Chirurgie (FRENCH). Neoadjuvant chemotherapy followed by chemoradiation and surgery with and without cetuximab in patients with resectable esophageal cancer: a randomized, open-label, phase III trial (SAKK 75/08). Ann Oncol. 2018 Jun 1;29(6):1386-1393. doi: 10.1093/annonc/mdy105.
Results Reference
result
PubMed Identifier
33055589
Citation
von Holzen U, Schmidt S, Hayoz S, Steffen T, Grieder F, Bartsch D, Schnider A, Knoefel WT, Piessen G, Kettelhack C, Marti WR, Schafer M, Fugger R, Koigsrainer A, Gloor B, Furrer M, Gerard MA, Hawle H, Walz MK, Alesina P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK), the German Esophageal Cancer Study Group, the Austrian Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT), the Federation Francophone de Cancerologie Digestive (FFCD)/Federation de Recherche en Chirurgie (FRENCH). Surgical Outcomes After Neoadjuvant Chemoradiation Followed by Curative Surgery in Patients With Esophageal Cancer: An Intergroup Phase III Trial of the Swiss Group for Clinical Cancer Research (SAKK 75/08). Ann Surg. 2022 Jun 1;275(6):1130-1136. doi: 10.1097/SLA.0000000000004334. Epub 2020 Aug 26.
Results Reference
derived
PubMed Identifier
32111181
Citation
Fehr M, Hawle H, Hayoz S, Thuss-Patience P, Schacher S, Riera Knorrenschild J, Durr D, Knoefel WT, Rumpold H, Bitzer M, Zweifel M, Samaras P, Mey U, Kung M, Winterhalder R, Eisterer W, Hess V, Gerard MA, Templeton A, Stahl M, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT); Federation Francophone de Cancerologie Digestive (FFCD) / Federation de Recherche en Chirurgie (FRENCH). High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08. BMC Cancer. 2020 Feb 28;20(1):166. doi: 10.1186/s12885-020-6623-z.
Results Reference
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Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

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