RECRUITING

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

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Conditions

Retroperitoneal SarcomaLiposarcomaLeiomyosarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Official Title

A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

Quick Facts

Study Start:2021-01-20
Study Completion:2028-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04031677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
  2. * LMS:
  3. * Any grade LMS can be included
  4. * Minimum size of LMS tumor should be 5 cm
  5. * LPS:
  6. * Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
  7. * All grade 3 DDLPS can be included.
  8. * DDLPS with confirmed grade 2 on biopsy can be included when:
  9. * The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).
  10. * The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)
  11. * Unifocal tumour
  12. * Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.
  13. * Criteria for non-resectability are:
  14. * Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or portal vein
  15. * Involvement of bone
  16. * Growth into the spinal canal
  17. * Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium
  18. * Infiltration of multiple major organs like liver, pancreas and or major vessels
  19. * Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen \& pelvis
  20. * Collection of tumour tissue for central pathology review is mandatory.
  21. * For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.
  22. * If tumour tissue is not available for the central pathology review, patient will not be eligible.
  23. * If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.
  24. * For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.
  25. * Collection of tumour tissue and blood samples for translational research is mandatory.
  26. * In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he/she will be eligible.
  27. * If the blood samples are not collected, patient will not be eligible.
  28. * If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he/she fulfils all other eligibility criteria
  29. * ≥ 18 years old (no upper age limit)
  30. * WHO performance status ≤ 2
  31. * Adequate haematological and organ function
  32. * American Society of Anaesthesiologist (ASA) score \< 3
  33. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.
  34. * WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  35. * For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
  36. * Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.
  37. * Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
  1. * Sarcoma originating from bone structure, abdominal or gynecological viscera
  2. * Extension through the sciatic notch or across the diaphragm
  3. * Metastatic disease
  4. * Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
  5. * Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
  6. * Congestive heart failure
  7. * Angina pectoris
  8. * Myocardial infarction within 1 year before randomization
  9. * Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mm Hg despite optimal medical therapy.
  10. * Uncontrolled cardiac arrhythmia
  11. * Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
  12. * Active and uncontrolled infections
  13. * Vaccination with live vaccines within 30 days prior to study entry
  14. * Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
  15. * Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.
  16. * Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.
  17. * Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
  18. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
  19. * Known contraindication to imaging tracer and to MRI
  20. 2. Selection criteria for STREXIT 2
  21. * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases)
  22. * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.
  23. * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.
  24. 3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy

Contacts and Locations

Study Contact

EORTC HQ
CONTACT
+3227741611
1809@eortc.org

Study Locations (Sites)

Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
UC Irvine Health/Chao Family Comprehensive Ca Ctr
Orange, California, 92668
United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
United States
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut, 06437
United States
Smilow Cancer Hospital Care Ctr at Saint Francis
Hartford, Connecticut, 06105
United States
Yale University
New Haven, Connecticut, 06520
United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06385
United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois at Chicago MBCCOP
Chicago, Illinois, 60612
United States
Indiana Univ/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
University of Kansas Hospital-Westwood Cancer Ctr
Westwood, Kansas, 66205
United States
James Graham Brown Ca Ctr at Univ of Louisville
Louisville, Kentucky, 40202
United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
United States
Our Lady of The Lake Hospital
Baton Rouge, Louisiana, 70808
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
United States
Johns Hopkins Univ/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21205
United States
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Siteman Cancer Center-West County
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South Country
Saint Louis, Missouri, 63129
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
United States
Nebraska Medicine-Bellevue
Omaha, Nebraska, 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
Lebanon, New Hampshire, 03756
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
Laura and Issac Perlmutter Ca Ctr at NYU Langone
New York, New York, 10016
United States
University of Rochester
Rochester, New York, 14642
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544
United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
United States
Forbes Hospital
Monroeville, Pennsylvania, 15146
United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84132
United States
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia, 23116
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth Univ/Massey Cancer Center
Richmond, Virginia, 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970
United States
FHCC South Lake Union
Seattle, Washington, 98109
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Marshfield Medical Center
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center
Rice Lake, Wisconsin, 54868
United States
Marshfield Med Ctr-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-20
Study Completion Date2028-04-21

Study Record Updates

Study Start Date2021-01-20
Study Completion Date2028-04-21

Terms related to this study

Additional Relevant MeSH Terms

  • Retroperitoneal Sarcoma
  • Liposarcoma
  • Leiomyosarcoma