This phase 2 trial is examining the effectiveness of FOLFOX chemotherapy to treat patients with rectal cancer, without surgery and radiation. The main outcome to be measured will be the tumor response to the treatment. This study is being conducted in New York, US.
The details
This year an estimated 44,180 people will be diagnosed with rectal cancer. The standard treatment for this disease is surgery, chemotherapy and radiation therapy. However, the surgery can be very invasive leaving the patients with a high rate of complications. FOLFOX chemotherapy consists of a combination of fluorouracil, leucovorin, and oxaliplatin. Chemotherapy helps to treat cancer by attacking and killing cancer cells. It is not clear how FOLFOX chemotherapy can affect patients without the use of radiation and surgery.
This phase 2 trial is examining the effectiveness of FOLFOX chemotherapy to treat patients with rectal cancer, without surgery and radiation. The main outcome to be measured will be the tumor response to the treatment.
Who are they looking for?
This trial is recruiting 40 patients with locally advanced rectal cancer. Patients must have an operable tumor and adequate bone marrow, liver, and kidney function. Female patients must not be pregnant and must use effective birth control during the study. Patients must be able to undergo MRI (imaging test).
Patients must not have metastasis, history of pelvic radiation, cancer treatment within the past 3 years. These patients must also not have infections, heart disease in the past 6 months or any other severe disease. Female patients must not be pregnant or breastfeeding.
How will it work
All patients will be assigned to receive 10 cycles of FOLFOX treatment, given every other week. FOLFOX will be given over day 1 of each cycle over 46 hours.
Those who show tumor response will not undergo surgery, but they will be closely followed-up instead. The main outcome will be measured by the change in tumor size after treatment. Survival will be measured up to 5 years.
