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New stomach cancer combo shows promise in early trial

NCT ID NCT00512304

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2 study tested a combination of chemotherapy (FOLFIRI) and radiation with 5-fluorouracil in 63 patients with gastric cancer. The treatment was given either before or after surgery to remove the tumor. The goal was to see if this approach is feasible and less toxic than older regimens. The study focused on patients with locally advanced disease (T3 or N+) who had not yet developed metastases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FOLFIRI chemotherapy plus 5-fluorouracil and radiation
What this could lead to
If successful, this could point toward a more effective and less toxic treatment plan for gastric cancer patients after surgery.
What could go wrong
This is a small, early-phase feasibility study, so results may not apply to all patients. The treatment still involves significant side effects from chemotherapy and radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Start date

Aug 2007

Finished

Oct 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * gastric adenocarcinoma histologically confirmed * tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound) * performance status WHO\<2 * serum albumin \>30 gr/l * weight loss \< 10% in the next 6 months * signed informed consent form Exclusion Criteria: * metastatic disease * prior abdominal radiotherapy

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

Contacts and locations

Locations

  • University hospital

    Rouen, 76031, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.