Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
NCT ID: NCT00126269
Last Updated: 2006-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
192 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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The 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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cisplatin
gemcitabine
Eligibility Criteria
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Inclusion Criteria
* Evidence of CUP based on histologic examination
* Negative search for the primary tumor site using recommended guidelines
* Disease classified as good prognosis according to the French classification criteria: \*performance status \>2 and \*normal serum LDH
* No prior chemotherapy
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Karim FIZAZI, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Karim FIZAZI, Dr
Role: primary
Other Identifiers
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GEFCAPI O2
Identifier Type: -
Identifier Source: org_study_id