Informations générales (source: ClinicalTrials.gov)
A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2003
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.