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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
5-FU and oxaliplatin
5-FU
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

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

Inclusion Criteria: Minimum age: 18 years Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease No prior therapy except a diverting stoma ECOG PS less than or equal 2 Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min Written informed consent before randomization Exclusion Criteria: Pregnant or breast feeding women Fertile patients without adequate contraception during therapy Past or ongoing drug abuse or alcoholic excess Prior chemotherapy Prior radiotherapy to the pelvis Prior (within 4 weeks) or concurrent treatment with any other investigational agent Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; * active uncontrolled intercurrent infections or sepsis Peripheral neuropathy > 2 (NCI CTC AE grading) Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator Chronic diarrhea (> NCI CTC AE-Grad 1) Known allergy to substances containing platinum compounds Concurrent use of the antiviral agent sorivudine or chemically related analogues Known deficiency of dehydropyrimidindehydrogenase (DPD)

Sites / Locations

  • Kreiskliniken Altötting-Burghausen
  • Gesundheitszentrum St. Marien
  • Onkologische Gemeinschaftspraxis
  • Krankenhaus Marienwörth
  • Caritas-Krankenhaus
  • Onkologische Schwerpunktpraxis
  • Klinik Bad Trissl-Oberaudorf
  • Klinikum Bayreuth GmbH
  • Aerzteforum Hennigsdorf
  • Städtische Kliniken
  • St.-Agnes-Hospital Bocholt
  • St. Josef-Hospital
  • Ruhr-Universität Bochum; Knappschaftskrankenhaus
  • Klinikum Bremen-Mitte
  • Onkologische Praxis
  • Praxis für Hämatologie und Onkologie
  • Klinikum Coburg gGmbH
  • Onkologisches Versorgungszentrum Rehling-Donauwörth-Dachau
  • Universitätsklinikum Carl Gustav Carus
  • Katholisches Krankenhaus St. Nepomuk
  • Dept. of Radiation Therapy, University of Erlangen
  • Universitätsklinikum Essen
  • Alfried Krupp Krankenhaus
  • Klinikum Esslingen a.N.
  • Universitätsklinikum
  • Universitätsklinikum Freiburg
  • Weisseritztal-Kliniken
  • Kliniken an der Paar, Krankenhaus Friedberg
  • Klinikum Fulda
  • SRH-Waldklinikum
  • Wilhelm-Anton-Hospital
  • Universitätsklinikum Greifswald
  • Klinik am Eichert
  • Georg-August-Universität Göttingen
  • St. Elisabeth und St. Barbara Krankenhaus
  • Asklepios Klinik Hamburg-Harburg
  • Diakonie Klinikum Hamburg
  • Praxis für Hämatologie und Onkologie, Hamm
  • Marienhospital
  • Onkologische Schwerpunktpraxis
  • Universitätsklinikum des Saarlandes
  • Klinik für Knochenmarkstransplantation und Hämatologie/Onkologie GmbH
  • Klinikum der Friedrich Schiller Universität
  • Innere Medizin, Hämatologie und Int. Onkologie
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Onkologische Schwerpunktpraxis
  • Praxis für Hämatologie und Onkologie
  • Gemeinschaftspraxis für Hämatologie und Internistische Onkologie
  • Gemeinschaftspraxis Onkologie
  • Klinikum Landshut
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Universitätsklinikum - St. Hildegardis-Krankenhaus Mainz
  • Phillips-Universität Marburg
  • Gemeinschaftspraxis Onkologie
  • Klinikum Schwäbisch Gmünd, Stauferklinik
  • Kliniken Maria Hilf
  • Universitätsklinikum Großhadern
  • Klinikum rechts der Isar, Technische Universität
  • Clemenshospital Münster
  • Universitätsklinikum Münster
  • Hämatologisch-onkologische Schwerpunktpraxis Northeim
  • Klinikum Nürnberg
  • Darmzentrum Ortenau
  • Klinikum Oldenburg; Pius Hospital Oldenburg
  • Paracelsus-Krankenhaus Ruit
  • St. Vincenz Krankenhaus
  • Klinikum Passau
  • St. Josefs Krankenhaus
  • Universitätsklinikum Regensburg
  • Schwerpunktpraxis für Hämatologie und Onkologie mit Tagesklinik
  • Krankenhaus Barmherzige Brüder
  • Klinikum Rosenheim
  • Medizinische Fakultät der Universität Rostock
  • Kreiskrankenhaus Rottweil
  • Thüringen-Kliniken Saalfeld-Rudolstadt
  • Hämatologisch-Onkologische Schwerpunktpraxis
  • Onkologische Praxisgemeinschaft Stade
  • Klinikum Traunstein
  • Onkologische Schwerpunktpraxis Traunstein
  • Krankenhaus der Barmherzigen Brüder
  • Universitätsklinikum Ulm
  • Marienhaus Klinikum, St. Elisabeth Klinik Saarlouis, St. Michael Krankenhaus Völklingen
  • Klinikum Wetzlar-Braunfels
  • Asklepios Paulinen Klinik
  • Reinhard-Nieter-Krankenhaus
  • Juliusspital
  • Missionsärztliche Klinik
  • Universitätsklinikum Würzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Preoperative simultaneous radiochemotherapy: 5-Fluorouracil und Oxaliplatin: Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35 Adjuvant Chemotherapy: Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours; repeat day 15, 8 cycles

Preoperative simultaneous radiochemotherapy: 5-Fluorouracil Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; 5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles

Outcomes

Primary Outcome Measures

Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first.

Secondary Outcome Measures

Resection rate, rate of sphincter preservation, tumor regression, cumulative incidence of local and distant recurrences, overall survival, toxicity, quality of life

Full Information

First Posted
July 5, 2006
Last Updated
July 29, 2016
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00349076
Brief Title
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer
Official Title
Prospective Randomised Multicenter Phase-III-study: Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil Plus Oxaliplatin Versus Preoperative Radiochemotherapy and Adjuvant Chemotherapy With 5-Fluorouracil for Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

5. Study Description

Brief Summary
Standard treatment for locally advanced cancer of the rectum is preoperative chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with 5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet, still 36% of all patients develop distant metastasis. Therefore, our new study (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the control of distant metastases. It is our hypothesis that the rate of disease free survival will improve by 5 to 8% after 3 years of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Preoperative simultaneous radiochemotherapy: 5-Fluorouracil und Oxaliplatin: Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35 Adjuvant Chemotherapy: Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours; repeat day 15, 8 cycles
Arm Title
2
Arm Type
Active Comparator
Arm Description
Preoperative simultaneous radiochemotherapy: 5-Fluorouracil Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; 5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles
Intervention Type
Drug
Intervention Name(s)
5-FU and oxaliplatin
Intervention Description
Preoperative radiochemotherapy: Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35 Adjuvant Chemotherapy: Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours repeat day 15, 8 cycles
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Preoperative radiochemotherapy: 5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles
Primary Outcome Measure Information:
Title
Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Resection rate, rate of sphincter preservation, tumor regression, cumulative incidence of local and distant recurrences, overall survival, toxicity, quality of life
Time Frame
5-year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum age: 18 years Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease No prior therapy except a diverting stoma ECOG PS less than or equal 2 Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min Written informed consent before randomization Exclusion Criteria: Pregnant or breast feeding women Fertile patients without adequate contraception during therapy Past or ongoing drug abuse or alcoholic excess Prior chemotherapy Prior radiotherapy to the pelvis Prior (within 4 weeks) or concurrent treatment with any other investigational agent Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; * active uncontrolled intercurrent infections or sepsis Peripheral neuropathy > 2 (NCI CTC AE grading) Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator Chronic diarrhea (> NCI CTC AE-Grad 1) Known allergy to substances containing platinum compounds Concurrent use of the antiviral agent sorivudine or chemically related analogues Known deficiency of dehydropyrimidindehydrogenase (DPD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Sauer, M.D.
Organizational Affiliation
Dept. of Radiation Therapy, University of Erlangen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kreiskliniken Altötting-Burghausen
City
Altötting
ZIP/Postal Code
84503
Country
Germany
Facility Name
Gesundheitszentrum St. Marien
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Facility Name
Krankenhaus Marienwörth
City
Bad Kreuznach
ZIP/Postal Code
55543
Country
Germany
Facility Name
Caritas-Krankenhaus
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
Klinik Bad Trissl-Oberaudorf
City
Bad Trissl
ZIP/Postal Code
83080
Country
Germany
Facility Name
Klinikum Bayreuth GmbH
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Aerzteforum Hennigsdorf
City
Berlin
ZIP/Postal Code
16761
Country
Germany
Facility Name
Städtische Kliniken
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
St.-Agnes-Hospital Bocholt
City
Bocholt
ZIP/Postal Code
46397
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Ruhr-Universität Bochum; Knappschaftskrankenhaus
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Onkologische Praxis
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
Praxis für Hämatologie und Onkologie
City
Burgwedel
ZIP/Postal Code
30938
Country
Germany
Facility Name
Klinikum Coburg gGmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Onkologisches Versorgungszentrum Rehling-Donauwörth-Dachau
City
Donauwörth
ZIP/Postal Code
86609
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Katholisches Krankenhaus St. Nepomuk
City
Erfurt
ZIP/Postal Code
99097
Country
Germany
Facility Name
Dept. of Radiation Therapy, University of Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Alfried Krupp Krankenhaus
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Klinikum Esslingen a.N.
City
Esslingen
ZIP/Postal Code
73073
Country
Germany
Facility Name
Universitätsklinikum
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Weisseritztal-Kliniken
City
Freital
ZIP/Postal Code
01705
Country
Germany
Facility Name
Kliniken an der Paar, Krankenhaus Friedberg
City
Friedberg
ZIP/Postal Code
86316
Country
Germany
Facility Name
Klinikum Fulda
City
Fulda
ZIP/Postal Code
36013
Country
Germany
Facility Name
SRH-Waldklinikum
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Wilhelm-Anton-Hospital
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
Universitätsklinikum Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Klinik am Eichert
City
Göppingen
ZIP/Postal Code
73035
Country
Germany
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
St. Elisabeth und St. Barbara Krankenhaus
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Asklepios Klinik Hamburg-Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Diakonie Klinikum Hamburg
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Praxis für Hämatologie und Onkologie, Hamm
City
Hamm
ZIP/Postal Code
59071
Country
Germany
Facility Name
Marienhospital
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinik für Knochenmarkstransplantation und Hämatologie/Onkologie GmbH
City
Idar-Oberstein
ZIP/Postal Code
55743
Country
Germany
Facility Name
Klinikum der Friedrich Schiller Universität
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Innere Medizin, Hämatologie und Int. Onkologie
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24015
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Praxis für Hämatologie und Onkologie
City
Köln
ZIP/Postal Code
50677
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Internistische Onkologie
City
Köln
ZIP/Postal Code
51105
Country
Germany
Facility Name
Gemeinschaftspraxis Onkologie
City
Landshut
ZIP/Postal Code
84028
Country
Germany
Facility Name
Klinikum Landshut
City
Landshut
ZIP/Postal Code
84034
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum - St. Hildegardis-Krankenhaus Mainz
City
Mainz
ZIP/Postal Code
65131
Country
Germany
Facility Name
Phillips-Universität Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Gemeinschaftspraxis Onkologie
City
Muhr am See
ZIP/Postal Code
91735
Country
Germany
Facility Name
Klinikum Schwäbisch Gmünd, Stauferklinik
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Kliniken Maria Hilf
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Universitätsklinikum Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar, Technische Universität
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Clemenshospital Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Hämatologisch-onkologische Schwerpunktpraxis Northeim
City
Northeim
ZIP/Postal Code
37154
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Darmzentrum Ortenau
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Klinikum Oldenburg; Pius Hospital Oldenburg
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Paracelsus-Krankenhaus Ruit
City
Ostfildern
ZIP/Postal Code
73760
Country
Germany
Facility Name
St. Vincenz Krankenhaus
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Klinikum Passau
City
Passau
ZIP/Postal Code
94032
Country
Germany
Facility Name
St. Josefs Krankenhaus
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Schwerpunktpraxis für Hämatologie und Onkologie mit Tagesklinik
City
Regensburg
ZIP/Postal Code
93047
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Medizinische Fakultät der Universität Rostock
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Kreiskrankenhaus Rottweil
City
Rottweil
ZIP/Postal Code
78628
Country
Germany
Facility Name
Thüringen-Kliniken Saalfeld-Rudolstadt
City
Saalfeld
ZIP/Postal Code
07318
Country
Germany
Facility Name
Hämatologisch-Onkologische Schwerpunktpraxis
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Onkologische Praxisgemeinschaft Stade
City
Stade
ZIP/Postal Code
21680
Country
Germany
Facility Name
Klinikum Traunstein
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Traunstein
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Marienhaus Klinikum, St. Elisabeth Klinik Saarlouis, St. Michael Krankenhaus Völklingen
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Klinikum Wetzlar-Braunfels
City
Wetzlar
ZIP/Postal Code
35578
Country
Germany
Facility Name
Asklepios Paulinen Klinik
City
Wiesbaden
ZIP/Postal Code
65197
Country
Germany
Facility Name
Reinhard-Nieter-Krankenhaus
City
Wilhelmshaven
ZIP/Postal Code
26389
Country
Germany
Facility Name
Juliusspital
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Missionsärztliche Klinik
City
Würzburg
ZIP/Postal Code
97074
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer

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