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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)

Phase 2
18 Years
Not Enrolling
Gastric Cancer, Stomach Cancer

Thank you

Trial Information

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)

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.

Inclusion Criteria:

- 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

- Patients at least 18 years of age with performance status 0-2 (Appendix B of the
study protocol).

- 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

- Each patient must sign the Informed Consent Form.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

toxicity of IP FUDR after surgery prior to chemoradiation

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Franco Muggia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:

02-51 (H 10610)



Start Date:

December 2002

Completion Date:

February 2012

Related Keywords:

  • Gastric Cancer
  • Stomach Cancer
  • stomach cancer
  • gastroesophageal junction cancer
  • GEJ cancer
  • intraperitoneal
  • adjuvant chemoradiation therapy
  • resection of advanced stomach cancer
  • locally advanced stomach cancer
  • Stomach Neoplasms



Bellevue Hospital New York, New York  10016
NYU Cancer Center New York, New York  10016
NYU Tisch Hospital New York, New York  10016