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Soft Tissue SarcomaPhase 2T-DISNCT01303094

Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

A Phase 2 study testing Trabectedin and Drug: holiday in people with Soft Tissue Sarcoma and Uterine Sarcoma, run by Centre Oscar Lambret at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomization discontinuation trial will allow for concomitant evaluation of the following: Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle Side effects and benefits of a drug holiday Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma, Uterine Sarcoma
What is being tested?
Trabectedin and Drug: holiday
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
16 sitesFrance
Study dates
Feb 2011to 9 Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma
  • Measurable lesions (RECIST 1.1)
  • Performance status ≤ 2
  • Age ≥ 18
  • Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
  • Adequate biological parameters :
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  • Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
  • Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
  • Albumin ≥ 25 g/L
  • Adequate renal function : Serum creatinine ≤ 1.5 x ULN
  • Creatine phosphokinase ≤ 2.5 x ULN
  • Adequate central venous access
  • Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
  • Patient covered by government health insurance
  • Information sheet given to the patient (Patient information sheet 1)
  • Patient registered in the selection part
  • Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment
  • Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle
  • Performance status ≤ 2
  • Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle
  • Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)
  • Adequate biological parameters :
  • Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)
  • Alkaline phosphatases ≤ 2.5 x ULN, If Alkaline phosphatases ≥ 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
  • Albumin ≥ 25 g/L
  • Adequate renal function : Serum creatinine ≤ 1.5 x ULN
  • Creatine phosphokinase (CPK) ≤ 2.5 x ULN
  • Adequate central venous access
  • Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
  • Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)

Who cannot join

  • Patients that have received more than one regimen of chemotherapy for metastatic or inoperable soft tissue or uterine sarcoma, after the failure/intolerance of doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line
  • The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas
  • Single tumour in an irradiated region
  • Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)
  • Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
  • Presence of known leptomeningeal or brain metastasis
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  • Patients unable to receive corticotherapy
  • Any circumstance that could jeopardise compliance or proper follow-up during the trial
  • Pregnant or nursing women
  • Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles
  • Non-availability of baseline scans prior to the first cycle and following the sixth cycle
  • Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
  • Presence of known leptomeningeal or brain metastasis
  • Creatinine clearance less than 30 ml/min
  • Patients unable to receive corticotherapy
  • Any circumstance that could jeopardise compliance or proper follow-up during the trial
  • Pregnant or nursing women
  • Hypersensitivity to Trabectedin or any excipient in prior cycles

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Saint-Jacques Hospital

    Besançon, 25 000

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Léon Bérard Center

    Lyon, 69 008

  • Centre Léon Bérard

    Lyon, 69008

  • Paoli Calmette Institute

    Marseille, 13 273

  • CHU Timone Adultes

    Marseille, 13385

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie

    Paris, 75005

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Huguenin

    Saint-Cloud, 92210

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle

This randomization discontinuation trial will allow for concomitant evaluation of the following:

  • Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
  • Side effects and benefits of a drug holiday
Read the detailed description

Selection part (220 patients):

Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin)

Randomized part (50 patients):

After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or "intermittent/holiday" therapy with CT-scan evaluation every 6 weeks in both arms

  • Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance
  • Arm B "Intermittent/holiday" therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance
Being tested
Trabectedin, Drug: holiday
Medical subject headings
Sarcoma

What participants receive

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

  • TrabectedinDrug

    Also called Yondelis

    Trabectedin will be administered without drug holiday in Arm A until unacceptable toxicity, progressive disease or patient decision. The treatment beyond disease progression and in case of intolerance will be decided according to investigator discretion. In case of progression after drug discontinuation by patient decision, a re-challenge of Trabectedin is possible.

  • Drug: holidayOther

    Also called No drug

    A drug-holiday will start after the 6th cycle until disease progression, and then Trabectedin will be re-challenged. Trabectedin will be administered until unacceptable toxicity, second evidence of progressive disease or patient decision.

Study groups in NCT01303094
Study groupRoleWhat they receive
Continuation of TrabectedinOtherpatient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity
Receives: Drug: Trabectedin
"Drug holiday" therapyOtherpatient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle and he stops the drug until progression and re-challenge
Receives: Other: Drug: holiday

What is being measured

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

  1. PFS rate 24 weeks after randomization

    In each arms among non progressive patients after the 6 first cycles of Trabectedin : occurrence of progression or death 24 weeks after the date of randomization. Intention to treat analysis. Centralised radiological review.

    Measured: 24 weeks after randomization

Secondary outcomes (8)

  1. Response rate

    stabilisation, complete and partial responses according to RECIST 1.1

    Measured: 6, 12 and 18 weeks after randomization

  2. Progression free survival rates

    According to RECIST 1.1

    Measured: 12 and 54 weeks after randomization

  3. Survival rates

    Measured: 12 and 24 months after randomization

  4. Median progression-free and median overall survivals

    Measured: Up to 5 years after randomization

  5. Tolerability - safety

    According to NCI-CTC V4.0 scale

    Measured: Up to 30 days after the last study drg administration

  6. Clinical and biological predictive factors for non progression at the 6th cycle

    Collected data at baseline : age, gender, comorbidity, disease history, previous treatment, tumor description, biological parameters

    Measured: At baseline

  7. Post-randomization cost of care

    Cost of care will be evaluated by macro-costing approach

    Measured: For one year after randomization

  8. Self estimation of general health status

    Evaluation every 6 weeks by 100-mm-long horizontal visual analog scale (VAS) that ranged from worst imaginable health (as bad as death, 0) to perfect health

    Measured: For 1 year after randomization

Timeline

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

  1. First posted24 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completion16 May 2018
  4. Study completion9 Aug 2018

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303094
Sponsor's protocol ID
T-DIS-1001
Other IDs
2010-022613-26
Acronym
T-DIS
Status last verified
Mar 2026
First submitted
23 Feb 2011
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

    PubMed 25680558

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trabectedin and Drug: holiday in people with Soft Tissue Sarcoma and Uterine Sarcoma, run by Centre Oscar Lambret at 16 sites in France.

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 30 inclusion and 18 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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS rate 24 weeks after randomization (time frame: 24 weeks after randomization). 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 NCT01303094, which also lists 1 linked publication.

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 16 Mar 2026.

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