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Personalized chemo shows promise against rare sarcomas

NCT ID NCT01710176

Disease control Sponsor: Italian Sarcoma Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether giving chemotherapy based on the specific type of soft tissue sarcoma works better than a one-size-fits-all approach. 550 adults with high-risk sarcomas in the arms or trunk were randomly assigned to standard chemo or a chemo regimen matched to their tumor type. The main goal was to see if the tailored approach improves disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy drugs (epirubicin, ifosfamide, gemcitabine, docetaxel, trabectedin, etoposide, dacarbazine)
What this could lead to
If successful, this could show that matching chemotherapy to the specific sarcoma subtype improves the chance of keeping the cancer from coming back.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely confirmed. The benefit may vary by sarcoma subtype, and chemotherapy has significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

550 people

The number who actually took part.

Started

Jun 2011

Finished

Jun 2024

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Soft tissue sarcoma of adults, primary or locally recurrent, with spindle-cell or pleomorphic histology, belonging to one of the following for the randomization (Group1): myxoid-Round Cell liposarcoma (cellular component \>5 %), leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheat tumor, undifferentiated pleomorphic sarcoma (ex Malignant fibrous histiocytoma) Or belonging to one of the following for the registration (Group 2): myxofibrosarcoma, unclassified Spindle Cell, pleomorphic liposarcoma, pleomorphic rabdomiosarcoma Or belonging to either group but not being evaluable for response (re-excision after previous inadequate resection or primary definitive surgery) (Group3). The histological diagnosis must be made according to the WHO criteria and will have to be centrally reviewed before randomization. 2. High malignancy grade: grade 3 of 3, according to Coindre, or grade 2 at biopsy with a radiological evidence of more than 50% of necrosis in the tumor mass. 3. Deep seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall)lesion. 4. Size of primary tumor (visible or previously inadequately resected) \>5 cm at instrumental staging (CT, MRI), or locally recurrent of any size. 5. Age \> 18 years. 6. ECOG performance status \<1. 7. Adequate bone marrow function: WBC \>3.500/mm3 neutrophil \>1.500/mm3 platelets \>150.000/mm3 hemoglobin \>11 g%. 8. Adequate renal (creatinine \<1.3 mg%), and hepatic function (bilirubin \<1.5 mg% and transaminases \<2 x n.v. If ALP \> 2.5 x ULN, ALP LF and/or GGT \< ULN). 9. Adequate cardiac function (FE \>50%). 10. Signed informed consent. 11. Complete compliance of the participating center with the protocol requirements. Exclusion Criteria: 1. Pregnancy or lactation. 2. Distant metastasis. 3. Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent. 4. Sarcoma histotypes other than those mentioned in the inclusion criteria. 5. Prior CT and/or RT. 6. Serious psychiatric disease that precludes informed consent or limits compliance. 7. Medical disease limiting survival to less than two years, limiting compliance or which in the physician's opinion might interfere significantly with the toxicity of the treatments. 8. Cardiovascular diseases resulting in a New York Heart Association Functional Status \> 2. 9. Uncontrolled bacterial, viral or fungal infection. 10. Impossibility of ensuring adequate follow-up. 11. Failure to comply with the requirements of the present protocol leading to exclusion of the participating center.

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma malignant peripheral nerve sheath tumor myxofibrosarcoma myxoid/round cell liposarcoma pleomorphic liposarcoma pleomorphic rhabdomyosarcoma soft tissue sarcoma spindle cell sarcoma synovial sarcoma undifferentiated pleomorphic sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Localized high-risk soft tissue sarcomas of the extremities and trunk wall in adults

Contacts and locations

Locations

  • Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -

    Candiolo, TO, Italy

  • Hospital Clínico de Malaga

    Málaga, Spain

  • Hospital Son Espases

    Palma de Mallorca, Spain

  • Hospital Vall D'Hebron

    Barcelona, Spain

  • Irccs Centro Di Riferimento Oncologico (Cro) -

    Aviano (PN), Italy

  • Irccs Istituto Clinico Humanitas -

    Rozzano (MI), Italy

  • Irccs Istituto Europeo Di Oncologia (Ieo) -

    Milan, Italy

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Italy

  • Irccs Istituto Nazionale Tumori Fondazione Pascale -

    Naples, Italy

  • Irccs Istituto Oncologico Veneto (Iov)

    Padova, Italy

  • Irccs Istituto Ortopedico Rizzoli (Ior) -

    Bologna, Italy

  • Irccs Istituto Regina Elena (Ifo)

    Roma, Italy

  • Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori -

    Meldola (FC), Italy

  • Pres.Ospedal.Spedali Civili Brescia -

    Brescia, Italy

  • Presidio Sanitario Gradenigo Di Torino

    Torino, Italy

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