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.
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
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.
Norway2 sites, 2 recruiting
- 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
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.
- Conditions
- Soft Tissue Sarcoma
- 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 group | Role | What they receive |
|---|---|---|
| Sequential ifosfamide and doxorubicin | Experimental | Four 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.
Overall response rate
Partial or complete response using RECIST v1.1
Measured: Up to 16 weeks
Secondary outcomes (2)
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
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.
- First posted1 Mar 2021
- Study start27 Apr 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Kjetil Boye, Oslo University Hospital
- Investigators
- Kjetil Boye, MD PhD, Principal investigator, Oslo University Hospital
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