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Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma (STRASS)

Primary Purpose

Sarcoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
therapeutic conventional surgery
3-dimensional conformal radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult malignant fibrous histiocytoma, adult malignant mesenchymoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following:

    • Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
    • Sarcoma not originated from bone structure, abdominal, or gynecological viscera
    • Unifocal tumor (not multifocal disease)
    • Absence of extension through the sciatic notch or across the diaphragm

  • The following histological sub-types are not allowed:

    • Gastrointestinal stromal tumor (GIST)
    • Rhabdomyosarcomas
    • Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma
    • Osteosarcoma or chondrosarcoma
    • Aggressive fibromatosis
    • Sarcomatoid or metastatic carcinoma
  • No metastatic disease
  • Untreated disease

  • Tumor must be operable and suitable for radiotherapy, based on the following criteria:

    • Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection)

      • No surgery anticipated to be R2 on the CT scan before randomization
    • Must have American Society of Anesthesiologist (ASA) score ≤ 2

    • None of the following unresectable criteria:

      • Involvement of superior mesenteric artery
      • Involvement of aorta
      • Involvement of bone
  • Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast)

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • WBC ≥ 2,500/mm^3
  • Platelet count ≥ 80,000/mm^3
  • Total bilirubin < 1.5 times the upper limit normal
  • Calculated creatinine clearance normal
  • Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram
  • Adequate cardiac function (NYHA class I-II)
  • ECG normal (without clinically significant abnormalities)

  • No history of any of the following disorders:

    • Bowel obstruction
    • Mesenteric ischemia
    • Severe chronic inflammatory bowel disease
  • Negative pregnancy test
  • Not pregnant or nursing concurrently and for at least 1 month after the surgery
  • Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery
  • No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy
  • No prior abdominal or pelvic irradiation for another prior malignancy or other disease
  • No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy)
  • No postoperative radiotherapy planned

Sites / Locations

  • Dana-Farber Cancer Institute & Harvard Medical School
  • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
  • U.Z. Gasthuisberg
  • Mount Sinai Hospital
  • CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame
  • University Copenhagen
  • Institut Bergonie
  • Centre Leon Berard
  • Institut Gustave Roussy
  • Universitaetsklinikum
  • UniversitaetsMedizin Mannheim
  • Klinikum der Universitaet
  • Technische Universitaet Muenchen
  • Centro Di Riferimento Oncologico
  • Istituto Clinico Humanitas
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Oncologico Veneto
  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
  • University Medical Center Groningen
  • Leiden University Medical Centre
  • Radboud University Medical Center
  • Radium Hospitalet
  • Maria Sklodowska-Curie Memorial Cancer Center
  • Hospital General Vall d'Hebron
  • Hospital Universitario San Carlos
  • Karolinska University Hospital
  • Queen Elizabeth Medical Center
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
  • General Western Hospital
  • Beatson-Gartnavel General Hospital
  • Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital
  • University College Hospital
  • Royal Marsden Hospital - Chelsea, London
  • Christie NHS Foundation Trust
  • Freeman Hospital
  • Nottingham University Hospitals NHS Trust - City Hospital campus
  • Weston Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery alone

Preoperative radiotherapy followed by en-bloc surgery

Arm Description

En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.

3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions

Outcomes

Primary Outcome Measures

Number of Patients With Abdominal Recurrence or Death
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.

Secondary Outcome Measures

Acute Toxicity Profile of Preoperative Radiotherapy.
The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: Grade 0 No event reported Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
Perioperative Complications
Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
Late Complications
The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: Grade 0 no event Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
Tumor Response to Preoperative Radiotherapy
For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.
Number of Patients With an Abdominal Recurrence
Abdominal recurrence was defined in the ARFS section. The following are considered competing events: death in the absence of abdominal failure distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
Number of Patients With Metastases or Death
Alive and metastases free patients will be censored at the date of last follow-up.
Number of Patients Alive
Alive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.

Full Information

First Posted
April 27, 2011
Last Updated
April 21, 2023
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT01344018
Brief Title
Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma
Acronym
STRASS
Official Title
A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
Detailed Description
OBJECTIVES: Primary To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery. Secondary To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients. To assess tumor response in patients undergoing preoperative radiotherapy. To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to institution and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following randomization. Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass within 4-8 weeks after the completion of RT. Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery to identify new prognostic factors for translational research. After completion of study therapy, patients are followed at day 60 post-surgery and every 6 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult malignant fibrous histiocytoma, adult malignant mesenchymoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery alone
Arm Type
Active Comparator
Arm Description
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
Arm Title
Preoperative radiotherapy followed by en-bloc surgery
Arm Type
Experimental
Arm Description
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Primary Outcome Measure Information:
Title
Number of Patients With Abdominal Recurrence or Death
Description
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
Time Frame
ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
Secondary Outcome Measure Information:
Title
Acute Toxicity Profile of Preoperative Radiotherapy.
Description
The acute toxicity was assessed in randomized patients who received at least one dose of preoperative radiotherapy (RT). It follows Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in the RT safety population, assuming the following classification: Grade 0 No event reported Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. For each item of the CTCAE, the worst grade of acute toxicity from the data of randomization prior to surgery was taken
Time Frame
From date of randomization to the date of surgical procedure, prior to surgery
Title
Perioperative Complications
Description
Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
Time Frame
From the date of surgery, up to 60 days following surgery
Title
Late Complications
Description
The late toxicities occurring more than 60 days after surgery. These were reported using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. This scales the observed toxicity from Grade 1 to 5, assuming the following classification: Grade 0 no event Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Full AE reporting can be found in the Adverse Event Section.
Time Frame
From day 60 after surgery till end of follow-up, up to 7 years
Title
Tumor Response to Preoperative Radiotherapy
Description
For patients that received preoperative radiotherapy, the tumor response was assessed using RECIST 1.1. Response criteria were essentially based on a set of measurable lesions identified at baseline as target lesions, and followed at the end of the radiotherapy. Response was not the primary endpoint, so a confirmatory CT-scan was not mandatory.
Time Frame
Two weeks after completion of Pre-operative Radiotherapy, before Surgery
Title
Number of Patients With an Abdominal Recurrence
Description
Abdominal recurrence was defined in the ARFS section. The following are considered competing events: death in the absence of abdominal failure distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.
Time Frame
ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years
Title
Number of Patients With Metastases or Death
Description
Alive and metastases free patients will be censored at the date of last follow-up.
Time Frame
Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.
Title
Number of Patients Alive
Description
Alive patients were censored at the date of last follow-up. Causes of death were recorded and reported as a table.
Time Frame
Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following: Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis Sarcoma not originated from bone structure, abdominal, or gynecological viscera Unifocal tumor (not multifocal disease) Absence of extension through the sciatic notch or across the diaphragm The following histological sub-types are not allowed: Gastrointestinal stromal tumor (GIST) Rhabdomyosarcomas Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma Osteosarcoma or chondrosarcoma Aggressive fibromatosis Sarcomatoid or metastatic carcinoma No metastatic disease Untreated disease Tumor must be operable and suitable for radiotherapy, based on the following criteria: Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection) No surgery anticipated to be R2 on the CT scan before randomization Must have American Society of Anesthesiologist (ASA) score ≤ 2 None of the following unresectable criteria: Involvement of superior mesenteric artery Involvement of aorta Involvement of bone Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast) PATIENT CHARACTERISTICS: WHO performance status 0-2 WBC ≥ 2,500/mm^3 Platelet count ≥ 80,000/mm^3 Total bilirubin < 1.5 times the upper limit normal Calculated creatinine clearance normal Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram Adequate cardiac function (NYHA class I-II) ECG normal (without clinically significant abnormalities) No history of any of the following disorders: Bowel obstruction Mesenteric ischemia Severe chronic inflammatory bowel disease Negative pregnancy test Not pregnant or nursing concurrently and for at least 1 month after the surgery Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy No prior abdominal or pelvic irradiation for another prior malignancy or other disease No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy) No postoperative radiotherapy planned
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Bonvalot
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rick LM Haas, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber Cancer Institute & Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame
City
Montreal QUEBEC
State/Province
Quebec
ZIP/Postal Code
1560
Country
Canada
Facility Name
University Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
UniversitaetsMedizin Mannheim
City
Mannheim
Country
Germany
Facility Name
Klinikum der Universitaet
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Technische Universitaet Muenchen
City
Muenchen
Country
Germany
Facility Name
Centro Di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Centre
City
Leiden
ZIP/Postal Code
2300
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
Radium Hospitalet
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center
City
Warsaw
ZIP/Postal Code
02781
Country
Poland
Facility Name
Hospital General Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
60500
Country
Sweden
Facility Name
Queen Elizabeth Medical Center
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
City
Bristol
Country
United Kingdom
Facility Name
General Western Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson-Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital
City
Leeds
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Chelsea, London
City
London
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital campus
City
Nottingham
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32941794
Citation
Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.
Results Reference
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Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma

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