Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT00126269
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-07', 'studyFirstSubmitDate': '2005-08-02', 'studyFirstSubmitQcDate': '2005-08-02', 'lastUpdatePostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Progression-free survival'}, {'measure': 'Toxicity'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis'], 'conditions': ['Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.\n\nThe purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Evidence of CUP based on histologic examination\n* Negative search for the primary tumor site using recommended guidelines\n* Disease classified as good prognosis according to the French classification criteria: \\*performance status \\>2 and \\*normal serum LDH\n* No prior chemotherapy\n* No previous carcinoma, except basal-cell carcinoma of the skin\n* Adequate renal function: measured or calculated creatinine clearance \\> 60 ml/min\n* Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients infected by the Human Immunodeficiency Virus (HIV)\n* CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man\n* Patients who do not fit inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00126269', 'briefTitle': 'Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis', 'orgStudyIdInfo': {'id': 'GEFCAPI O2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'gemcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karim FIZAZI, Dr', 'role': 'CONTACT', 'email': 'fizazi@igr.fr', 'phone': '33 1 42114559'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Karim FIZAZI, Dr', 'role': 'CONTACT', 'email': 'fizazi@igr.fr', 'phone': '33 1 42114559'}], 'overallOfficials': [{'name': 'Karim FIZAZI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}}}}