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AzTrials

Gastric CancerPhase 2NCT00858338

Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer

A Phase 2 study testing Potentially curative surgery, Floxuridine (IP) and Adjuvant Chemoradiation therapy in people with Gastric Cancer and Stomach Cancer, run by NYU Langone Health at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip) Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative stomach resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Stomach Cancer
What is being tested?
Potentially curative surgery, Floxuridine (IP) and Adjuvant Chemoradiation therapy
Type of treatment
Surgery or procedure
How many people
28 participants
Where
3 sitesUnited States
Study dates
Dec 2002to Feb 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligibility to the protocol is established following complete evaluation specified under 9.2 of the study protocol. This evaluation includes the diagnosis and disease stage. Untreated patients with histologically documented gastric/GEJ carcinoma stages IB-IV (Mo), become eligible.
  • Patients who underwent emergency surgery for indications such as gastrointestinal obstruction, perforation or hemorrhage, or patients with surgery already performed, are eligible as long as the surgery is considered curative (Ro) as specified in section 9.3 of the study protocol.
  • A device for adjuvant ip chemotherapy has to be in situ, placed during the surgery or early (1-3 weeks) thereafter. Time elapsed since the surgery must not exceed 4 weeks.
  • Patient's diagnosis and staging, based on postoperative pathological findings, has to confirm stage IB-IV Mo adenocarcinoma of the stomach or GEJ. Patients and their clinical records must be evaluated by protocol surgical, radiation and medical oncologists, and sections of resected primary tumor and lymph nodes by protocol surgical pathologist.
  • Each patient has to undergo pretreatment evaluation, sign Informed Consent, and be registered.
  • Patients at least 18 years of age with performance status 0-2 (Appendix B of the study protocol).
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  • An adequate bone-marrow reserve (segmented neutrophils and bands, at least 1,500/ mmL, thrombocytes at least 100,000 /mmL, hemoglobin at least 9 gm/dL).
  • Preserved liver and renal function (total serum bilirubin <2 mg/dL, SGOT/SGPT not greater than 2.5x the upper limit of normal, alkaline phosphatase not greater than 2.5x the upper limit of normal, BUN not greater than 30 mg/dL, creatinine concentration not greater than 1.5 mg/dL or creatinine clearance >60 mL/min), and negative BHcG in females of reproductive potential, are required.
  • Patient must have evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. If only one kidney is present, at least two thirds of the functioning kidney must be excluded from any radiation port.
  • The prothrombin time, activated partial thromboplastin time, and thrombin time should be within the range of normal values.
  • All patients and records must be evaluated by a Surgical, Radiation and Medical Oncologists within one month before their entry to this protocol. There should be a reasonable assurance that patient will be available for planned post-treatment follow-up.
  • Each patient must sign the Informed Consent Form.

Who cannot join

  • Patients who do not meet criteria specified in inclusion criteria, and patients who have received prior RT, chemotherapy or immunotherapy.
  • Patients with another active invasive malignancy. Adequately treated basal cell or squamous cell skin cancer, in-situ cervix cancer, or other cancers the patient has been free for at least 5 years, are acceptable.
  • Patients with active or uncontrolled infection including HIV.
  • Patients with psychiatric disorders that would interfere with their consent.
  • Pregnant and nursing patients. Patients of reproductive age may not participate unless they agree to use an effective contraceptive method.
  • Patients with any other severe concurrent disease, which in judgment of protocol investigators would make the patient inappropriate for this study.
  • Protocol patients who did not receive ip FUDR treatment for complications related to catheter insertion or maintenance. However, these patients may still undergo off-protocol chemoradiation.
  • Patients who did not sign written informed consent.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Bellevue Hospital

    New York, New York, 10016

  • NYU Cancer Center

    New York, New York, 10016

  • NYU Tisch Hospital

    New York, New York, 10016

Other trials in United States

About this study

Official title: Phase-II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation (5-fluorouracil/Leucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy) in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma (R0 Resection and at Least D1 Lymph-node Dissection)

This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip) Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative stomach resection.

Read the detailed description

Most patients diagnosed with stomach cancer in the US fail to be cured by gastric resection, and most trials of adjuvant chemotherapy do not improve survival rates. However, it has shown that chemo-radiotherapy can substantially increase survival rates after gastric resection in a recent intergroup randomized study (INT 0116) that used adjuvant chemoradiation of 5-fluorouracil (5-FU) and leucovorin concurrently with total dose of 4500 cGy of external-beam radiation treatment (RT) to the abdominal tumor nodal field in patients with resected, locally advanced gastric cancer. However, since the most common recurrences in both arms (surgery only vs. surgery followed by chemoradiation) were regional, typically abdominal carcinomatosis, this may indicate the need for adjuvant ip floxuridine to be added to adjuvant chemoradiation. Our experience for ip floxuridine leads us to hypothesize that the addition of this type of therapy to adjuvant chemoradiation may further increase the cure-rate for patient under-going potentially curative gastric resection. It seems important to convincingly demonstrate the effect of ip floxuridine treatment combined with the chemoradiation regimen. This became the basis for the design of this Phase II study, which will test the toxicity and efficacy of ip floxuridine added to chemo-radiation of the INT 0116 study. The protocol is to be completed in three years, and it may become a springboard for planning and initiation of a pivotal multi-institutional trials.

Being tested
Potentially curative surgery, Floxuridine (IP), Adjuvant Chemoradiation therapy
Keywords
stomach cancer, gastroesophageal junction cancer, GEJ cancer, intraperitoneal, adjuvant chemoradiation therapy, resection of advanced stomach cancer, locally advanced stomach cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Potentially curative surgeryProcedure or surgery

    Surgery:

    Week 1: Potentially curative surgery. If the tumor successfully resected (microscopically disease-free margins, Ro, with regional lymphadenectomy for proper staging), the ip catheter in place.

    Weeks 2-4: Recovery. Then continue to adjuvant IP chemotherapy.

  • Floxuridine (IP)Drug

    Also called FUDR

    Adjuvant IP Chemotherapy:

    week 1: ip Floxuridine 3 gm/day, days 1,2,3. week 2: 1 week without treatment. week 3: ip Floxuridine 3 gm/day protocol days 15,16,17. week 4: 1 week without treatment. Then continue to chemoradiation therapy.

  • Adjuvant Chemoradiation therapyProcedure or surgery

    Adjuvant Chemoradiation therapy:

    week 1: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-4; week 9: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-3; week 14: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; week 19: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. toxicity of IP FUDR after surgery prior to chemoradiation

    Measured: 6 months

Secondary outcomes (2)

  1. overall survival

    every 4 months the first year after treatment; every 6 months 2nd and 3rd year; yearly thereafter up to a total 10 years

    Measured: up to 10 years

  2. Time to relapse, disease specific survival

    every 4 months the first year after treatment; every 6 months 2nd and 3rd year; yearly thereafter up to a total 10 years

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2009 (estimated)
  2. Study startDec 2002
  3. Primary completionMar 2007
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858338
Sponsor's protocol ID
02-51 (H 10610)
Status last verified
Mar 2016
First submitted
6 Mar 2009
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Potentially curative surgery, Floxuridine (IP) and Adjuvant Chemoradiation therapy in people with Gastric Cancer and Stomach Cancer, run by NYU Langone Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicity of IP FUDR after surgery prior to chemoradiation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00858338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.

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