Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT03943667
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2019-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
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FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.'}, {'pmid': '38232341', 'type': 'DERIVED', 'citation': 'De La Fouchardiere C, Malka D, Cropet C, Chabaud S, Raimbourg J, Botsen D, Launay S, Evesque L, Vienot A, Perrier H, Jary M, Rinaldi Y, Coutzac C, Bachet JB, Neuzillet C, Williet N, Desgrippes R, Grainville T, Aparicio T, Peytier A, Lecomte T, Roth GS, Thirot-Bidault A, Lachaux N, Bouche O, Ghiringhelli F. Gemcitabine and Paclitaxel Versus Gemcitabine Alone After 5-Fluorouracil, Oxaliplatin, and Irinotecan in Metastatic Pancreatic Adenocarcinoma: A Randomized Phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER Study. J Clin Oncol. 2024 Mar 20;42(9):1055-1066. doi: 10.1200/JCO.23.00795. Epub 2024 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof\n* Age ≥18 years\n* At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area\n* Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2\n* Life expectancy ≥12 weeks\n* Negative serology (HIV, hepatitis B and C)\n* Adequate organs function\n* Proven Post-menopausal status or negative urinary or serum pregnancy test\n* Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment\n* Patients affiliated to the social security system\n* Patient must have signed a written informed consent form\n\nExclusion Criteria:\n\n* Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri\n* Known cerebral metastasis\n* Uncontrolled severe infections\n* Patients with Kaposi's sarcoma\n* Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0\n* Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)\n* Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient\n* Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment\n* Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial\n* Participation in another clinical trial within 14 days prior to randomization\n* Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced"}, 'identificationModule': {'nctId': 'NCT03943667', 'acronym': 'GEMPAX', 'briefTitle': 'Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'UC-0110/1809'}, 'secondaryIdInfos': [{'id': '2018-002886-21', 'type': 'EUDRACT_NUMBER'}, {'id': 'PRODIGE 65 - UCGI 36', 'type': 'OTHER', 'domain': 'UNICANCER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEMPAX', 'description': 'Gemcitabine + Paclitaxel until progression', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Gemcitabine alone until progression', 'interventionNames': ['Drug: Gemcitabine']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['GEMZAR'], 'description': '1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.', 'armGroupLabels': ['Control', 'GEMPAX']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['TAXOL'], 'description': '80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.', 'armGroupLabels': ['GEMPAX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayeux', 'country': 'France', 'facility': 'CH 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Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Européen de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Saint-Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montbéliard', 'country': 'France', 'facility': 'Hôpital Nord Franche Comté', 'geoPoint': {'lat': 47.50957, 'lon': 6.79823}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75011', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'country': 'France', 'facility': 'Institut Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'St-Malo', 'country': 'France', 'facility': 'Hôpital Broussais', 'geoPoint': {'lat': 48.64738, 'lon': 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