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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04031677


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04031677
Ethics application status
Date submitted
22/07/2019
Date registered
24/07/2019

Titles & IDs
Public title
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Scientific title
A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
Secondary ID [1] 0 0
EA7211
Secondary ID [2] 0 0
EORTC 1809-STBSG
Universal Trial Number (UTN)
Trial acronym
STRASS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retroperitoneal Sarcoma 0 0
Liposarcoma 0 0
Leiomyosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Surgery
Treatment: Drugs - Preoperative chemotherapy

Other: Standard arm - Surgery alone

Experimental: Experimental arm - Preoperative chemotherapy and surgery


Treatment: Surgery: Surgery
Large en-bloc curative-intent surgery

Treatment: Drugs: Preoperative chemotherapy
* High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks
* LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks

Note: the recommended dose of Doxorubicin (or Epirubicin) can be modified according to national/institutional guidelines, given that the minimal threshold must be Doxorubicin 60 mg/m2 per cycle (or the equivalent Epirubicin 95 mg/m2 per cycle); the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimal threshold must be 7.5 g/m2 per cycle; the recommended dose of Dacarbazine can be modified according to national/institutional guidelines, given that the minimal threshold must be 900 mg/m2 per cycle. The schedule of administration of above chemotherapies can be modified according to national/institutional guidelines provided that the minimal threshold of doses, and the treatment periods with chemotherapies remain the same.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival
Timepoint [1] 0 0
7 years from first patient in
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
8 years from first patient in
Secondary outcome [2] 0 0
Recurrence free survival
Timepoint [2] 0 0
8 years from first patient in
Secondary outcome [3] 0 0
Distant metastases free survival
Timepoint [3] 0 0
8 years from first patient in
Secondary outcome [4] 0 0
Cumulative incidence of local recurrences
Timepoint [4] 0 0
8 years from first patient in
Secondary outcome [5] 0 0
Cumulative incidence of distant metastases
Timepoint [5] 0 0
8 years from first patient in
Secondary outcome [6] 0 0
Radiological response to neoadjuvant chemotherapy according to RECIST
Timepoint [6] 0 0
8 years from first patient in
Secondary outcome [7] 0 0
Radiological response to neoadjuvant chemotherapy according to CHOI
Timepoint [7] 0 0
8 years from first patient in
Secondary outcome [8] 0 0
Pathological response
Timepoint [8] 0 0
8 years from first patient in
Secondary outcome [9] 0 0
Safety and toxicity of neoadjuvant chemotherapy
Timepoint [9] 0 0
8 years from first patient in
Secondary outcome [10] 0 0
Perioperative complications
Timepoint [10] 0 0
8 years from first patient in
Secondary outcome [11] 0 0
Late complications
Timepoint [11] 0 0
8 years from first patient in
Secondary outcome [12] 0 0
Health-Related Quality of life (EORTC QLQ-C30 + Item list from QLQ-STO22)
Timepoint [12] 0 0
8 years from first patient in
Secondary outcome [13] 0 0
Health utility, calculated from the collected patient-reported HRQoL data and patient demographics economics.
Timepoint [13] 0 0
8 years from first patient in

Eligibility
Key inclusion criteria
1. STRASS 2


* Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
* LMS:

* Any grade LMS can be included
* Minimum size of LMS tumor should be 5 cm
* LPS:

* 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.
* All grade 3 DDLPS can be included.
* DDLPS with confirmed grade 2 on biopsy can be included when:

* 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).
* The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)
* Unifocal tumour
* 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.
* Criteria for non-resectability are:
* Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or portal vein
* Involvement of bone
* Growth into the spinal canal
* Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium
* Infiltration of multiple major organs like liver, pancreas and or major vessels
* 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
* Collection of tumour tissue for central pathology review is mandatory.
* For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.
* If tumour tissue is not available for the central pathology review, patient will not be eligible.
* 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.
* 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.
* Collection of tumour tissue and blood samples for translational research is mandatory.
* 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.
* If the blood samples are not collected, patient will not be eligible.
* If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he/she fulfils all other eligibility criteria
* = 18 years old (no upper age limit)
* WHO performance status = 2
* Adequate haematological and organ function
* American Society of Anaesthesiologist (ASA) score < 3
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.

Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.
* 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.
* 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.
* 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.
* Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
* Sarcoma originating from bone structure, abdominal or gynecological viscera
* Extension through the sciatic notch or across the diaphragm
* Metastatic disease
* Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
* Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
* Congestive heart failure
* Angina pectoris
* Myocardial infarction within 1 year before randomization
* Uncontrolled arterial hypertension defined as blood pressure = 150/100 mm Hg despite optimal medical therapy.

Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be = 150/90mmHg in order for a patient to be eligible for the study.
* Uncontrolled cardiac arrhythmia
* 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
* Active and uncontrolled infections
* Vaccination with live vaccines within 30 days prior to study entry
* Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
* Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason = 6prostate cancer.
* Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.
* 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.
* 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
* Known contraindication to imaging tracer and to MRI
2. Selection criteria for STREXIT 2

* 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)
* Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.
* 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.
3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy

All patients recruited to STRASS 2 in participating centres (Australia +/- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/04/2028
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - University Of Queensland - Woolloongabba
Recruitment hospital [2] 0 0
Peter Maccallum Cancer Institute - Melbourne
Recruitment hospital [3] 0 0
Chris O'Brian Life House - Chris O'Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 0 0
QLD 4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Hampshire
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Toronto
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France
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France
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Germany
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Dresden
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Mannheim
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Aviano
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Candiolo
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Padova
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Italy
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Roma
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Japan
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Fukuoka
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Nagoya
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Saitama
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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Poland
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Warsaw
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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Madrid
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Birmingham
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Glasgow
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Leeds
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London
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Newcastle
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Nottingham
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Oxford
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Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Cancer Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ECOG-ACRIN Cancer Research Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Anticancer Fund, Belgium
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Australia and New Zealand Sarcoma Association
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Japan Clinical Oncology Group
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
EORTC HQ
Address 0 0
Country 0 0
Phone 0 0
+3227741611
Fax 0 0
Email 0 0
1809@eortc.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04031677

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 89
Peter MacCallum Cancer Centre
Recruitment postcode(s) [1] 93
3000
Funding & Sponsors
Funding source category [1] 72
Government body
Name [1] 72
NHMRC - Medical Research Future Fund (MRFF) - 2020 Rare Cancers Rare Diseases and Unmet Need (RCRDUN)
Address [1] 72
GPO Box 1421 Canberra ACT 2601
Country [1] 72
Australia
Funding source category [2] 73
Other Collaborative groups
Name [2] 73
European Organisation for Research and Treatment of Cancer
Address [2] 73
Avenue Emmanuel Mounier 83/11 1200 Brussels Belgium
Country [2] 73
Belgium
Primary sponsor
Other Collaborative groups
Primary sponsor name
European Organisation for Research and Treatment of Cancer (EORTC)
Primary sponsor address
Avenue Emmanuel Mounier 83/11
1200 Brussels
Belgium
Primary sponsor country
Belgium
Secondary sponsor category [1] 74
Other Collaborative groups
Name [1] 74
Australia and New Zealand Sarcoma Association (ANZSA)
Address [1] 74
305 Grattan Street, Melbourne VIC 3000
Country [1] 74
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 47
Peter MacCallum Cancer Centre HREC
Address [1] 47
305 Grattan Street Melbourne VIC 3000
Country [1] 47
Australia
Date submitted for ethics approval [1] 47
11/06/2021
Approval date [1] 47
12/11/2021
Ethics approval number [1] 47
HREC/65094/PMCC
 
Public notes

Contacts
Principal investigator
Title 329 0
A/Prof
Name 329 0
Anne Hamilton
Address 329 0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Country 329 0
Australia
Phone 329 0
+61 3 85598339
Fax 329 0
Email 329 0
anne.hamilton@petermac.org
Contact person for public queries
Title 330 0
Ms
Name 330 0
Janina Chapman
Address 330 0
Clinical Trial Manager Australia and New Zealand Sarcoma Association 305 Grattan Street Melbourne VIC 3000
Country 330 0
Australia
Phone 330 0
+61 4 14316490
Fax 330 0
Email 330 0
janina.chapman@petermac.org
Contact person for scientific queries
Title 331 0
A/Prof
Name 331 0
Anne Hamilton
Address 331 0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Country 331 0
Australia
Phone 331 0
+61 3 85598339
Fax 331 0
Email 331 0
anne.hamilton@petermac.org