Comparison of Chemotherapy Combinations for Colon Cancer
Name of the Trial
Phase III Randomized Study of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL)
Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225)
after Curative Resection for Patients with Stage III Colon Cancer (NCCTG-N0147).
See the protocol summary.
Principal Investigators
|
Dr. Steven
Alberts
Principal Investigator |
Dr. Steven Alberts and Dr. Frank Sinicrope, North Central Cancer Treatment
Group.
Why is This Trial Important?
Colon cancer is among the most common cancer types in the United States. Surgery
is often used to treat colon cancer, but even with potentially curative
surgery, some cancer cells can remain in the body, especially if cancer has
spread to the surrounding lymph nodes (stage III colon cancer). To fight these
cancer cells, doctors may treat patients with post-operative (adjuvant) chemotherapy.
Biological agents, such as monoclonal antibodies, may also be added to the chemotherapy.
This trial will include six different treatment groups. Patients will be randomly
assigned to receive one of three different combinations of chemotherapy with
or without the monoclonal antibody cetuximab. Cetuximab targets a protein, epidermal
growth factor receptor, that may help some types of cancer cells to grow.
"For patients with lymph node involvement, the recurrence rate after surgery
is historically about 50 to 70 percent," said Dr. Alberts. "Traditional
adjuvant chemotherapy with fluorouracil and leucovorin, however, has produced
definite improvements. Our hope is that the more active agents now available
to us will further reduce the risk of recurrence without producing a lot of
additional side effects compared with current standard therapy.
"By comparing these different regimens, we hope to determine what will
become the state-of-the-art in adjuvant therapy for colon cancer," added
Dr. Alberts.
Who Can Join This Trial?
Researchers want to enroll 4,800 patients aged 18 and over, diagnosed with stage
III colon cancer, who have had their tumors surgically removed. See
the complete list of eligibility criteria.
Where Is This Trial Taking Place?
Multiple study sites in the United States are enrolling patients for this trial.
See
the full list of study sites.
Who to Contact
See the list
of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The call is toll free and completely confidential.
Back to Top |