Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
Phase 3
- Conditions
- Carcinoma
- Registration Number
- NCT00126269
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
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.
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
- Patients older than 18 years
- 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
- Patients infected by the Human Immunodeficiency Virus (HIV)
- 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
- Patients who do not fit inclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Toxicity Response rate Progression-free survival Quality of life
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France