ClinicalTrials.gg
Status unknownNCT00510107Updated Aug 1, 2007

Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

A Phase 2 interventional study of oxaliplatin and Cisplatin in Stomach Neoplasm, Stage IV and Recurrent, sponsored by Gachon University Gil Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-08-01.

Sponsored by Gachon University Gil Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

Read the detailed description

Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.

02

Conditions studied

  • Stomach Neoplasm
  • Stage IV
  • Recurrent
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 90 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • histologically proven gastric cancer
  • aged 75 years or less
  • performance status 0 to 2
  • no prior chemotherapy
  • inoperable, recurrent, or metastatic
  • normal marrow, hepatic and renal functions

Exclusion criteria

Exclusion Criteria:

  • active infections
  • severe co-morbidities
  • pregnant or lactating women
  • active brain metastasis
  • neuropathy of grade 2 or higher
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    1

    Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.

    Drug: Cisplatin

  • Experimental
    2

    Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.

    Drug: oxaliplatin

Interventions

  • oxaliplatin 120 mg/m2 will be given on day 1.

    Also known as: Eloxatin

  • Cisplatin 60 mg/m2 will be given on day 1.

06

What researchers measure

Primary outcomes

  1. response rate

Secondary outcomes

  1. safety

07

Study locations

1 of 1 sites recruiting
  • Gachon University Gil Medical Center
    Incheon, Incheon 405 760, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2007 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2007
First posted
Aug 1, 2007
Start
Jul 2007
CompletionEst.
Jul 2009
Last update
Aug 1, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00510107
Lead sponsor
Gachon University Gil Medical Center
Collaborators
Sanofi
First posted
Aug 1, 2007
Start date
Jul 2007
Completion
Jul 2009 (estimated)
Last update
Aug 1, 2007

Study contacts

Dong Bok Shin, MD, PhD
Contact
dbs@gilhospital.com
82 32 460 3682
Se Hoon Park, MD
principal investigator · Gachon University Gil Medical Center, Incheon, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. 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.

Studies of the drug tested here: Oxaliplatin

Start the discussion