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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Adenocarcinoma, Gastric 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


Inclusion Criteria:



- Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy
with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast
or other methods of imaging to confirm absence of metastatic dz) (Untreated patients
with histologically documented gastric/GEJ ca stages IB-IV [M0] are eligible)

- Based on post-op pathological findings, diagnosis and staging has to confirm stage
IB-IV (M0) adenocarcinoma of stomach or GEJ.

- Patients who underwent emergency surgery for indications such as GI obstruction,
perforation, or hemorrhage, or patients with surgery already performed, are eligible
provided surgery is considered curative

- ECOG performance status 0-2

- AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb
greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT
less than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln

- BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl >60 ml/min

- Negative b-HCG pregnancy test (females with reproductive potential)

- PT, aPTT, and thrombin time within range of normal

- Evidence of at least unilateral renal function as established by CT scan with
contrast or nephrogram. (If only one kidney is present, at least 2/3 of the
functioning kidney must be excluded from any RT port)

Exclusion Criteria:

- Prior radiation therapy, chemotherapy or immunotherapy

- Presence of another active invasive malignancy (Except for adequately treated basal
cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient
has been disease-free for at least 5 yrs)

- Active or uncontrolled infection, including HIV

- Psychiatric disorders that would interfere with informed consent· Pregnant or nursing
women (Patients of reproductive age must agree to use effective contraceptive method)

- Any other severe concurrent disease, which in the judgment of MD would make patient
inappropriate for study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

U.S.C./Norris Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

3G-03-1

NCT ID:

NCT00183911

Start Date:

November 2003

Completion Date:

April 2007

Related Keywords:

  • Gastric Adenocarcinoma
  • Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

U.S.C. / Norris Comprehensive Cancer CenterLos Angeles, California  90033