Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT01303094
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077606', 'term': 'Trabectedin'}, {'id': 'D000097042', 'term': 'Treatment Interruption'}], 'ancestors': [{'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS rate 24 weeks after randomization', 'timeFrame': '24 weeks after randomization', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '6, 12 and 18 weeks after randomization', 'description': 'stabilisation, complete and partial responses according to RECIST 1.1'}, {'measure': 'Progression free survival rates', 'timeFrame': '12 and 54 weeks after randomization', 'description': 'According to RECIST 1.1'}, {'measure': 'Survival rates', 'timeFrame': '12 and 24 months after randomization'}, {'measure': 'Median progression-free and median overall survivals', 'timeFrame': 'Up to 5 years after randomization'}, {'measure': 'Tolerability - safety', 'timeFrame': 'Up to 30 days after the last study drg administration', 'description': 'According to NCI-CTC V4.0 scale'}, {'measure': 'Clinical and biological predictive factors for non progression at the 6th cycle', 'timeFrame': 'At baseline', 'description': 'Collected data at baseline : age, gender, comorbidity, disease history, previous treatment, tumor description, biological parameters'}, {'measure': 'Post-randomization cost of care', 'timeFrame': 'For one year after randomization', 'description': 'Cost of care will be evaluated by macro-costing approach'}, {'measure': 'Self estimation of general health status', 'timeFrame': 'For 1 year after randomization', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma', 'Uterine Sarcoma']}, 'referencesModule': {'references': [{'pmid': '25680558', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This randomization discontinuation trial will allow for concomitant evaluation of the following:\n\n* Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle\n* Side effects and benefits of a drug holiday', 'detailedDescription': 'Selection part (220 patients):\n\nTrabectedin (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)\n\nRandomized part (50 patients):\n\nAfter 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\n\n* Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (for the selection part):\n\n* Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma\n* Measurable lesions (RECIST 1.1)\n* Performance status ≤ 2\n* Age ≥ 18\n* Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)\n* Adequate biological parameters :\n* Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)\n* 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\n* Albumin ≥ 25 g/L\n* Adequate renal function : Serum creatinine ≤ 1.5 x ULN\n* Creatine phosphokinase ≤ 2.5 x ULN\n* Adequate central venous access\n* Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods\n* Patient covered by government health insurance\n* Information sheet given to the patient (Patient information sheet 1)\n\nExclusion Criteria (for the selection part):\n\n* 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\n* The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas\n* Single tumour in an irradiated region\n* Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)\n* Currently active bacterial or fungus infection (\\> grade 2 CTC \\[CTCAE\\] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections\n* Presence of known leptomeningeal or brain metastasis\n* Patients unable to receive corticotherapy\n* Any circumstance that could jeopardise compliance or proper follow-up during the trial\n* Pregnant or nursing women\n\nInclusion Criteria (for the randomized part):\n\n* Patient registered in the selection part\n* Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment\n* Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle\n* Performance status ≤ 2\n* Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle\n* Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 100,000)\n* Adequate biological parameters :\n* Adequate hepatic function (bilirubin ≤ ULN , SGPT/ALT and SGOT/AST ≤ 2.5 x ULN)\n* 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\n* Albumin ≥ 25 g/L\n* Adequate renal function : Serum creatinine ≤ 1.5 x ULN\n* Creatine phosphokinase (CPK) ≤ 2.5 x ULN\n* Adequate central venous access\n* Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods\n* Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)\n\nExclusion Criteria (for the randomized part):\n\n* Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles\n* Non-availability of baseline scans prior to the first cycle and following the sixth cycle\n* Currently active bacterial or fungus infection (\\> grade 2 CTC \\[CTCAE\\] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections\n* Presence of known leptomeningeal or brain metastasis\n* Creatinine clearance less than 30 ml/min\n* Patients unable to receive corticotherapy\n* Any circumstance that could jeopardise compliance or proper follow-up during the trial\n* Pregnant or nursing women\n* Hypersensitivity to Trabectedin or any excipient in prior cycles"}, 'identificationModule': {'nctId': 'NCT01303094', 'acronym': 'T-DIS', 'briefTitle': 'Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'T-DIS-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Continuation of Trabectedin', 'description': 'patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity', 'interventionNames': ['Drug: Trabectedin']}, {'type': 'OTHER', 'label': '"Drug holiday" therapy', 'description': 'patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle and he stops the drug until progression and re-challenge', 'interventionNames': ['Other: Drug: holiday']}], 'interventions': [{'name': 'Trabectedin', 'type': 'DRUG', 'otherNames': ['Yondelis'], 'description': '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.', 'armGroupLabels': ['Continuation of Trabectedin']}, {'name': 'Drug: holiday', 'type': 'OTHER', 'otherNames': ['No drug'], 'description': '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.', 'armGroupLabels': ['"Drug holiday" therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25 000', 'city': 'Besançon', 'country': 'France', 'facility': 'Saint-Jacques Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69 008', 'city': 'Lyon', 'country': 'France', 'facility': 'Léon Bérard Center', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13 273', 'city': 'Marseille', 'country': 'France', 'facility': 'Paoli Calmette Institute', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Timone Adultes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Nicolas PENEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Sarcoma Group', 'class': 'OTHER'}, {'name': 'Study Group of Bone Tumors', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}