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A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon

Phase 3
Not Enrolling
Stage II Colon Cancer, Stage III Colon Cancer

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Trial Information

A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon


I. To compare the relative efficacy of 5-FU + LV + Oxaliplatin (FLOX) with that of 5-FU + LV
(FL) in prolonging DFS.


I. To compare the relative efficacy of FLOX with FL in prolonging S.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV (administered
after 1 hour of leucovorin calcium) weekly for 6 weeks.

ARM II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and leucovorin
calcium and fluorouracil as in arm I.

Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed at 6, 9, and 12 months; every 6 months for 4 years; and then annually

Inclusion Criteria:

- Patients must consent to be in the study and must have signed and dated an
IRB-approved consent form conforming to federal and institutional guidelines

- In the opinion of the investigator, patients must have a 10-year life expectancy,
excluding their diagnosis of cancer

- The interval between curative resection and randomization must be no more than 42

- The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy

- Patients must have colonic adenocarcinoma that meets one of the criteria below:

- Stage II carcinoma (T3, 4; N0; M0) - The tumor invades through the muscularis
propria into the subserosa, or into non-peritonealized pericolic or perirectal
tissues (T3) or directly invades other organs or structures, and/or perforates
visceral peritoneum (T4), excluding free perforation

- Stage III carcinoma (any T; N1, 2; M0) - The tumor has invaded to any depth,
with involvement of regional lymph nodes

- AGCs >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Bilirubin within or below the normal limits for the laboratory

- Alkaline phosphatase within or below the normal limits for the laboratory

- SGOT or SGPT within or below the normal limits for the laboratory

- Serum creatinine within or below the normal limits for the laboratory

- Patients with more than one synchronous primary colon tumor are eligible; for the
purpose of this protocol, staging classification will be based on the stage of the
more advanced primary tumor

- Patients are eligible if adjacent structures (e.g., bladder, small intestine, ovary,
etc.) involved by direct extension of the primary tumor are removed en bloc and if,
in the judgement of the surgeon and by confirmation on histological examination
(i.e., margins of resection are not involved), the resection is deemed to be

- Patients must have an ECOG performance status of 0, 1, or 2

- Patients with intestinal obstruction are eligible; preliminary or complementary
colostomy does not preclude entry

- Patients with prior noncolorectal malignancies are eligible if they have been
disease-free for >= 5 years; patients with squamous or basal cell carcinoma of the
skin that has been effectively treated, carcinoma in situ of the cervix that has been
treated by operation only, or lobular carcinoma in situ of the breast are eligible,
even if these conditions were diagnosed within 5 years prior to randomization

Exclusion Criteria:

- Prior invasive colon or rectal malignancy, regardless of disease-free interval

- Current or past malignant colon tumors other than carcinoma, i.e., sarcoma, lymphoma,
carcinoid, etc., regardless of disease-free interval

- Tumors located < 12 cm from the anal verge on preoperative endoscopy

- Tumors that demonstrate free perforation as manifested by free air or free fluid in
the abdomen; patients with walled-off perforation are eligible

- Pregnancy or lactation at the time of proposed randomization; (5-FU and oxaliplatin
are both teratogenic and mutagenic and may cause fetal harm;) eligible patients of
reproductive potential (both sexes) must agree to use adequate contraceptive methods

- Noncurative surgical resection or prior chemotherapy or radiotherapy for this
malignancy, with the exception of a decompressing colostomy

- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would
preclude the patient's receiving either chemotherapy treatment option; specifically
excluded are patients with active ischemic heart disease (class III or class IV
myocardial disease -- New York Heart Association) or a recent history of myocardial
infarction (within 6 months), or current symptomatic arrhythmia

- Class III: Patients with cardiac disease resulting in marked limitation of
physical activity; such patients are comfortable at rest; less-than-ordinary
physical activity causes fatigue, palpitation, dyspnea, or anginal pain

- Class IV: Patients with cardiac disease resulting in inability to perform any
physical activity without discomfort; symptoms of cardiac insufficiency or the
anginal syndrome may be present even at rest

- Psychiatric or addictive disorders that would preclude obtaining informed consent

- Multiple primary tumors involving both the colon and the rectum that would preclude
the patient's being classified as having only colon cancer

- Evidence of laparoscopically-assisted colectomy, unless patients are participating in
the Intergroup Protocol INT 0146 or the Australasian, Multi-center, Prospective,
Randomized, Clinical Study Comparing Laparoscopic and Conventional Open Surgical
Treatments of Colon Cancer in Adults (ALCCaS)

- Isolated, distant, or noncontiguous intra-abdominal metastases, even if resected,
will render the patient ineligible

- Clinically significant peripheral neuropathy at the time of randomization (defined in
the NCI Common Toxicity Criteria [CTC] as grade 2 or greater neurosensory or
neuromotor toxicity)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

DFS rate

Outcome Time Frame:

Time to first documented evidence of colon cancer recurrence, second primary cancer, or death from any cause without prior evidence of colon cancer recurrence or second primary cancer, assessed up to 3 years

Safety Issue:


Principal Investigator

John Kuebler

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Surgical Adjuvant Breast and Bowel Project (NSABP)


United States: Food and Drug Administration

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Stage II Colon Cancer
  • Stage III Colon Cancer
  • Colonic Neoplasms



National Surgical Adjuvant Breast and Bowel Project Pittsburgh, Pennsylvania  15212-5234