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Soft Tissue SarcomaPhase 2NCT04776525

Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma

A Phase 2 study testing Ifosfamide and Doxorubicin in people with Soft Tissue Sarcoma, run by Oslo University Hospital at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Ifosfamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesNorway
Study dates
27 Apr 2021to Dec 2037
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age at the time of informed consent.
  • Histological diagnosis of soft tissue sarcoma belonging to one of the following histotypes:
  • Leiomyosarcoma
  • Malignant peripheral nerve sheath tumor
  • Undifferentiated pleomorphic sarcoma
  • Myxofibrosarcoma
Show all 26Show fewer
  • Synovial sarcoma
  • Pleomorphic liposarcoma
  • Pleomorphic rhabdomyosarcoma
  • Unclassified spindle cell sarcoma
  • Malignancy grade ≥ 2 according to the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system.
  • Tumor localized in extremity, girdle and/or trunk wall.
  • Primary tumor size ≥5.0 cm as measured in the longest diameter on diagnostic MRI or CT scan.
  • Primary tumor location below the superficial fascia or involving the superficial fascia, i.e. deep-seated according to the World Health Organization (WHO) Classification of Tumors of Soft Tissue and Bone (4th edition, 2013).
  • The primary tumor must be available for biopsy collection at protocol inclusion.
  • Patients must have a measurable tumor according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Before patient registration, written informed consent must be given according to national and local regulations.
  • Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments:
  • Hemoglobin ≥ 8.0 g/dL
  • Neutrophil count ≥ 1.0 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 ml/min based on Cockcroft Gault estimation or direct measurement
  • Negative Hepatitis B and C and HIV serology.
  • Adequate contraception in women of childbearing potential (WOCBP) and their fertile partners during the study and until 6 months after end of study treatment. WOCBP should have a negative highly sensitive serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. A woman is considered fertile following menarche and until becoming post-menopausal unless permanently sterile. WOCBP should be willing to use one of the mentioned highly effective methods of birth control mentioned below or be surgically sterile, or abstain from heterosexual activity for the course of the study through 1 year after the last dose of study medication. Methods considered as highly effective birth control methods include combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, injectable, implantable or transdermal), intrauterine device (including hormone-releasing), male condom, bilateral tubal occlusion, vasectomised partner or sexual abstinence (see appendix 5 for definitions).

Who cannot join

  • Any prior therapy for soft tissue sarcoma.
  • Locoregional or distant metastasis as assessed by CT and/or MRI at time of diagnosis. Patients with lung nodules <10 mm of uncertain etiology may be included.
  • Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
  • Urinary obstruction.
  • Known hypersensitivity towards ifosfamide, doxorubicin or pegfilgrastim, their metabolites and other ingredients in the drug administration formulation.
  • New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of diagnosis of soft tissue sarcoma, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Show all 11Show fewer
  • Left ventricular ejection fraction (LVEF) < 50%.
  • Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.
  • Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
  • Any other significant comorbidities, such as active infection, uncontrolled pulmonary or liver disease, active cystitis, or any other condition, that based on the assessment of the treating physician could compromise compliance with the protocol or predispose the patient to safety risks.
  • Pregnant or lactating patients.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kjetil Boye, MD PhD contact

+4722934000

kjetil.boye@ous-hf.no

Norway2 sites, 2 recruiting

  • Haukeland University Hospital

    Bergen

    Tor-Christian Johannessen, MD, tor-christian.aase.johannessen@helse-bergen.no

    Recruiting

  • Oslo University Hospital

    Oslo

    Kjetil Boye, MD PhD, kjetil.boye@ous-hf.no

    Recruiting

Other trials in Norway

About this study

Official title: Sequential Neoadjuvant Ifosfamide and Doxorubicin in Localized High-grade Soft Tissue Sarcoma of Extremities and Trunk Wall

Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive factors for treatment response are lacking. The aim of this study is to explore sequential treatment with ifosfamide and doxorubicin in a neoadjuvant setting and to investigate biomarkers predictive of treatment response.

Being tested
Ifosfamide, Doxorubicin
Keywords
Doxorubicin, Ifosfamide, Sarcoma, Neoadjuvant, Sequential
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IfosfamideDrug

    Also called Holoxan

    3 g/m2 each day for three days

  • DoxorubicinDrug

    Also called Adriamycin

    80 mg/m2 over four hours day 1

Study groups in NCT04776525
Study groupRoleWhat they receive
Sequential ifosfamide and doxorubicinExperimentalFour cycles ifosfamide 9 g/m2 and four cycles doxorubicin 80 mg/m2. Each cycle has a duration of 14 days.
Receives: Drug: Ifosfamide; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Partial or complete response using RECIST v1.1

    Measured: Up to 16 weeks

Secondary outcomes (2)

  1. Incidence of treatment-related adverse events as assessed by CTCAE v5.0 and dose reductions (safety and tolerability)

    Number and type of adverse events, serious adverse events, dose reductions and discontinuation due to toxicity

    Measured: Until 30 days after last dose of study treatment

  2. Correlation between TP53 mutation assessed by sequencing of tumor DNA and overall response

    To investigate if TP53 mutations assessed by sequencing of tumor DNA predict response to high-dose alkylating chemotherapy and/or sequential doxorubicin monotherapy in STS

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start27 Apr 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04776525
Sponsor's protocol ID
44-2020
Status last verified
Oct 2026
First submitted
19 Feb 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ifosfamide and Doxorubicin in people with Soft Tissue Sarcoma, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kjetil Boye, MD PhD (+4722934000, kjetil.boye@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04776525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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