CClinicalTrials.gg
Sign In
Status unknownNCT00126269Updated Sep 8, 2006

Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary

A Phase 3 interventional study of cisplatin and gemcitabine in Carcinoma, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-09-08.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma

Browse trials for

Keywords

  • Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 192 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants

Interventions

  • Drugcisplatin
  • Druggemcitabine
06

What researchers measure

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Response rate

  2. Progression-free survival

  3. Toxicity

  4. Quality of life

07

Study locations

1 of 1 sites recruiting
  • Institut Gustave Roussy
    Villejuif, 94805, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00126269
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
First posted
Aug 3, 2005
Start date
May 2003
Last update
Sep 8, 2006

Study contacts

Karim FIZAZI, Dr
Contact
fizazi@igr.fr
33 1 42114559
Karim FIZAZI, Dr
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Start the discussion