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Soft Tissue Sarcoma of the Trunk and ExtremitiesSTARSNCT07265661

Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma

A study testing hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment and hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment in people with Soft Tissue Sarcoma of the Trunk and Extremities, run by Italian Sarcoma Group.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment and hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
No sites listed yet
Study dates
30 Jan 2027to 1 Dec 2035
Phase
Interventional
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

  • Voluntary written informed consent, with the ability to fully understand and effectively communicate, before performance of any study-related procedure not part of normal medical practice, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Age > 18 years
  • Proven diagnosis of primary, resectable extremity/trunk wall STS with low-medium risk (Sarculator© predicted 10y-OS > 60%)
  • Measurable disease criteria (RECIST 1.1 and CHOI)
  • ECOG: 0, 1 or 2 (if influenced by orthopedic condition and not by general status)
  • No major contraindication to the planned radiotherapy or surgical treatment
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  • Active participation with adherence to requested treatment schedule and follow-up
  • Female subject will undergo a negative pregnancy test
  • Adequate bone marrow function (hemoglobin > 9g/dL, Leukocytes > 3000/mm³, platelets > 100,000/mm³). Patients with plasma creatinine ≤ 1.6 mg/dL, transaminase (AST-SGOT, ALT-SGPT) ≤ 2.5 times the UNL; total bilirubin ≤ 1.5 time the UNL; alkaline phosphatase ≤ 2.5 times the UNL are acceptable. CRP, LDH, total protein and albumin must also be recorded.
  • HBV and HCV serologies must be performed prior to patient inclusion. If hepatitis B surface antigen (HBsAg) is positive, further evaluation is required to exclude active viral replication (i.e., testing for hepatitis B e antigen [HBeAg] and HBV DNA). If either of these markers is positive, study inclusion is not recommended. In such cases, prophylactic treatment with lamivudine may be considered at the investigator's discretion. If a potential participant tests positive for anti-HCV antibodies, active infection must be ruled out through a qualitative HCV PCR test. If PCR testing cannot be performed, or if it confirms active infection, the patient will not be eligible for the study. Patients must be HIV-seronegative, with a CD4+ T-cell count greater than 400/mm³. Individuals with clinically significant immunodeficiency-either congenital or acquired-are not eligible for enrollment

Who cannot join

  • Age < 18y
  • Soft tissue sarcomas (STS) originating at different sites (i.e., retroperitoneal, abdominal, pelvic, head and neck), gynecological sarcomas, as well as gastrointestinal stromal tumors (GISTs), desmoid-type fibromatosis and pediatric-type sarcomas (i.e., extraosseous Ewing sarcoma, embryonal/alveolar rhabdomyosarcoma, desmoplastic small round cell tumor) are excluded.
  • Recurrent or metastatic condition or previous whoop-surgery for sarcoma (incisional biopsies are allowed if performed 6 months before referral).
  • Unresectable tumors (with limb sparing surgery)
  • Diagnosed oncological condition in the 5 years before enrollment (exceptions: Gleason <6 prostatic adenocarcinoma; In-situ cervical cancer and melanoma; basal cell skin carcinoma radically treated)
  • Prior radiation treatment to the site designated for planned surgery or radiotherapy, regardless of indication
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  • Any medical condition that can impair and reduce life expectancy to less than 2 years including but not limited to significant systemic diseases grade 3 or higher on the CI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
  • Uncontrolled bacterial, fungal, or viral infections-either systemic or localized at the site of planned surgery or radiotherapy
  • Severe psychiatric disorder, psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent.
  • Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion
  • Patients who had received any other treatment for the disease under study including chemotherapy, radiotherapy, surgery or any other treatment with curative intent. incisional biopsies are allowed if performed 6 months before referral.
  • Inability to comply with the requested follow-up
  • Women who are pregnant or breast-feeding
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • BMI > 40 and BMI < 18

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gianluca Ignazzi contact

+393335359192

gianluca.ignazzi@italiansarcomagroup.org

Viviana Appolloni contact

+393756073789

viviana.appolloni@italiansarcomagroup.org

About this study

Official title: Surgical Timing After Preoperative Hypofractionated Radiotherapy for Patients With Primary Localized Soft Tissue Sarcoma of the Extremity and Trunk: a Randomized Phase 2 Clinical Trial

Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk.

Read the detailed description

This study is designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk. Eligible patients will be randomized to receive an ultra-hypofractionated RT regimen consisting of 30 Gy delivered in 5 fractions of 6 Gy, followed by surgical resection at one of two predefined intervals: either 1-2 weeks or 4-6 weeks after completion of radiotherapy. In parallel, a non-randomized observational cohort will be recorded, consisting of patients treated according to current standard practice - surgery alone or surgery preceded by nonventional RT (50 Gy in 25 fractions) - to provide a contemporaneous benchmark for comparison. The aim of this study is to gather high-quality clinical evidence on the impact of ultra-hypofractionated RT on oncologic outcomes, treatment-related toxicity, perioperative morbidity, and patient-reported quality of life. Evaluation of logistical and economic implications of treatment de-escalation, such as healthcare resource utilization and treatment burden are also an important point to be addressed.

By systematically assessing these endpoints, this study aims to inform future clinical guidelines and support the potential integration of ultra-hypofractionated RT into routine clinical practice for selected patients with localized STS.

Being tested
hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment, hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment

What participants receive

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

  • hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatmentProcedure or surgery

    hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment

  • hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatmentProcedure or surgery

    hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment

Study groups in NCT07265661
Study groupRoleWhat they receive
Group AExperimentalhypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment.
Receives: Procedure: hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment
Group BExperimentalhypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment.
Receives: Procedure: hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment
Observational cohortNo interventionStandard treatment with surgery ± standard radiotherapy (50Gy/25 fractions)

What is being measured

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

  1. Determine the incidence of postoperative complications

    The primary objective of this study is to determine the incidence of postoperative complications (according to Clavien-Dindo) within 90 days from surgery

    Measured: Day of surgery (DOS); 7-14-21-30-60-90 days post DOS; 4-8-12-16-20-24 months post DOS

Secondary outcomes (9)

  1. Quality of Life (QoL)

    Quality of Life (QoL)

    Measured: At last available QoL assessment date for patients without confirmed deterioration

  2. Overall Survival (OS)

    Overall Survival (OS)

    Measured: At the last date that patient was known to be alive

  3. Disease-Free Survival (DFS)

    Disease-Free Survival (DFS)

    Measured: Months 4-8-12-16-20-24 post surgery

  4. Cumulative Incidence of Local Recurrence (CCI-LR)

    Cumulative Incidence of Local Recurrence (CCI-LR)

    Measured: Months 4-8-12-16-20-24 post surgery

  5. Cumulative Incidence of Distant Metastasis (CCI-DM)

    Cumulative Incidence of Distant Metastasis (CCI-DM)

    Measured: Months 4-8-12-16-20-24 post surgery

  6. Pathological response

    Pathological response

    Measured: At any time during the study

  7. Radiological response (RECIST 1.1 and CHOI)

    Radiological response (RECIST 1.1 and CHOI)

    Measured: Months 4-8-12-16-20-24 post surgery

  8. Treatment-related toxicity

    Treatment-related toxicity (based on Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0)

    Measured: 7-14-21-30-60-90 days DOS, 4-8-12-16-20-24 months post DOS

  9. Postoperative complications

    Postoperative complications (classified according to Clavien-Dindo and CCI)

    Measured: 7-14-21-30-60-90 days DOS, 4-8-12-16-20-24 months post DOS

Timeline

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

  1. First posted5 Dec 2025
  2. Study start30 Jan 2027 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2035 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Group A (randomized): hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment. Group B (randomized): hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment. Observational cohort: standard treatment with surgery ± standard radiotherapy (50Gy/25 fractions)
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07265661
Sponsor's protocol ID
STARS
Acronym
STARS
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cury FL, Viani GA, Gouveia AG, Freire CVS, Grisi GA, Moraes FY. Meta-analysis of 5-day preoperative radiotherapy for soft tissue sarcoma (5D-PREORTS). Radiother Oncol. 2024 Jan;190:109935. doi: 10.1016/j.radonc.2023.109935. Epub 2023 Oct 25.

    PubMed 37884194

  • Guadagnolo BA, Baldini EH. Are We Ready for Life in the Fast Lane? A Critical Review of Preoperative Hypofractionated Radiotherapy for Localized Soft Tissue Sarcoma. Semin Radiat Oncol. 2024 Apr;34(2):180-194. doi: 10.1016/j.semradonc.2023.12.003.

    PubMed 38508783

  • Kosela-Paterczyk H, Teterycz P, Spalek MJ, Borkowska A, Zawadzka A, Wagrodzki M, Szumera-Cieckiewicz A, Morysinski T, Switaj T, Lugowska I, Castaneda-Wysocka P, Zdzienicki M, Goryn T, Rutkowski P. Efficacy and Safety of Hypofractionated Preoperative Radiotherapy for Primary Locally Advanced Soft Tissue Sarcomas of Limbs or Trunk Wall. Cancers (Basel). 2021 Jun 14;13(12):2981. doi: 10.3390/cancers13122981.

    PubMed 34198676

  • Bedi M, Singh R, Charlson JA, Kelly T, Johnstone C, Wooldridge A, Hackbarth DA, Moore N, Neilson JC, King DM. Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Adv Radiat Oncol. 2022 Jan 25;7(3):100850. doi: 10.1016/j.adro.2021.100850. eCollection 2022 May-Jun.

    PubMed 35647402

  • Kalbasi A, Kamrava M, Chu FI, Telesca D, Van Dams R, Yang Y, Ruan D, Nelson SD, Dry SM, Hernandez J, Chmielowski B, Singh AS, Bukata SV, Bernthal NM, Steinberg ML, Weidhaas JB, Eilber FC. A Phase II Trial of 5-Day Neoadjuvant Radiotherapy for Patients with High-Risk Primary Soft Tissue Sarcoma. Clin Cancer Res. 2020 Apr 15;26(8):1829-1836. doi: 10.1158/1078-0432.CCR-19-3524. Epub 2020 Feb 13.

    PubMed 32054730

  • Guadagnolo BA, Bassett RL, Mitra D, Farooqi A, Hempel C, Dorber C, Willis T, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Bishop AJ. Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1547-1557. doi: 10.1016/S1470-2045(22)00638-6. Epub 2022 Nov 4.

    PubMed 36343656

  • Bishop AJ, Mitra D, Farooqi A, Swanson DM, Hempel C, Willis T, Pearlnath C, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Guadagnolo BA. Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes. Cancer. 2025 Jan 1;131(1):e35542. doi: 10.1002/cncr.35542. Epub 2024 Aug 27.

    PubMed 39192597

  • Ahmed SK, Xu-Welliver M, Dorr M, Steinert KO, Houdek MT, Rose PS, Karim SM, Ashman JB, Goulding KA, Siontis BL, Haddock MG, Petersen IA. Hypofractionated Preoperative Radiation Therapy for Extremity and Superficial Trunk Soft Tissue Sarcomas: Results of a Prospective, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Nov 15;123(4):980-989. doi: 10.1016/j.ijrobp.2025.05.006. Epub 2025 May 17.

    PubMed 40389098

  • Kubicek GJ, Kim TW, Gutowski CJ, Kaden M, Eastwick G, Khrizman P, Xu Q, Lackman R. Preoperative Stereotactic Body Radiation Therapy for Soft-Tissue Sarcoma: Results of Phase 2 Study. Adv Radiat Oncol. 2021 Nov 20;7(2):100855. doi: 10.1016/j.adro.2021.100855. eCollection 2022 Mar-Apr.

    PubMed 35387414

  • Rosenberg SA, Tepper J, Glatstein E, Costa J, Baker A, Brennan M, DeMoss EV, Seipp C, Sindelar WF, Sugarbaker P, Wesley R. The treatment of soft-tissue sarcomas of the extremities: prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy. Ann Surg. 1982 Sep;196(3):305-15. doi: 10.1097/00000658-198209000-00009.

    PubMed 7114936

  • Gronchi A, Miah AB, Dei Tos AP, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Blay JY, Bolle S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brennan B, Brodowicz T, Buonadonna A, De Alava E, Del Muro XG, Dufresne A, Eriksson M, Fagioli F, Fedenko A, Ferraresi V, Ferrari A, Frezza AM, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Haas R, Hassan AB, Hecker-Nolting S, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kager L, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez-Pousa A, Martin-Broto J, Merimsky O, Messiou C, Mir O, Montemurro M, Morland B, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Strauss S, Sundby Hall K, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Casali PG, Stacchiotti S; ESMO Guidelines Committee, EURACAN and GENTURIS. Electronic address: clinicalguidelines@esmo.org. Soft tissue and visceral sarcomas: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021 Nov;32(11):1348-1365. doi: 10.1016/j.annonc.2021.07.006. Epub 2021 Jul 22. No abstract available.

    PubMed 34303806

  • Callegaro D, Miceli R, Bonvalot S, Ferguson P, Strauss DC, Levy A, Griffin A, Hayes AJ, Stacchiotti S, Pechoux CL, Smith MJ, Fiore M, Dei Tos AP, Smith HG, Mariani L, Wunder JS, Pollock RE, Casali PG, Gronchi A. Development and external validation of two nomograms to predict overall survival and occurrence of distant metastases in adults after surgical resection of localised soft-tissue sarcomas of the extremities: a retrospective analysis. Lancet Oncol. 2016 May;17(5):671-80. doi: 10.1016/S1470-2045(16)00010-3. Epub 2016 Apr 5.

    PubMed 27068860

  • Davis AM, O'Sullivan B, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Hammond A, Benk V, Kandel R, Goddard K, Freeman C, Sadura A, Zee B, Day A, Tu D, Pater J; Canadian Sarcoma Group; NCI Canada Clinical Trial Group Randomized Trial. Late radiation morbidity following randomization to preoperative versus postoperative radiotherapy in extremity soft tissue sarcoma. Radiother Oncol. 2005 Apr;75(1):48-53. doi: 10.1016/j.radonc.2004.12.020.

    PubMed 15948265

  • O'Donnell PW, Griffin AM, Eward WC, Sternheim A, Catton CN, Chung PW, O'Sullivan B, Ferguson PC, Wunder JS. The effect of the setting of a positive surgical margin in soft tissue sarcoma. Cancer. 2014 Sep 15;120(18):2866-75. doi: 10.1002/cncr.28793. Epub 2014 Jun 3.

    PubMed 24894656

  • Haas RL, Floot BGJ, Scholten AN, van der Graaf WTA, van Houdt W, Schrage Y, van de Ven M, Bovee JVMG, van Coevorden F, Vens C. Cellular Radiosensitivity of Soft Tissue Sarcoma. Radiat Res. 2021 Jul 1;196(1):23-30. doi: 10.1667/RADE-20-00226.1.

    PubMed 33914890

Questions about this trial

What is this clinical trial studying?

A study testing hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment and hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment in people with Soft Tissue Sarcoma of the Trunk and Extremities, run by Italian Sarcoma Group.

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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

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 Gianluca Ignazzi (+393335359192, gianluca.ignazzi@italiansarcomagroup.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the incidence of postoperative complications (time frame: Day of surgery (DOS); 7-14-21-30-60-90 days post DOS; 4-8-12-16-20-24 months post DOS). 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 NCT07265661, which also lists 22 linked publications.

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 2 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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