This trial, recruiting in China only, aims to evaluate whether adding bevacizumab (Avastin) to radiation and chemotherapy regimens is a more effective treatment for locally advanced rectal cancer (cancer that has started to infiltrate surrounding tissues). The main outcome being investigated is tumor regression (shrinkage) following the addition of bevacizumab.
The details
Bevacizumab (Avastin) is a therapy that targets a specific protein: vascular endothelial growth factor. This protein is used by the body and tumors to grow new blood vessels. Blocking the growth of blood vessels can starve the tumor, decreasing growth and shrinking the tumor.
This study will evaluate whether adding bevacizumab to a neoadjuvant regimen of chemotherapy and radiation (therapy undertaken prior to surgical removal of the tumor) assists in tumor regression (shrinkage). The outcomes measured include rate of tumor regression, survival rates, and safety (level of toxicity caused by the addition of bevacizumab).
Who are they looking for?
This study will enroll 45 patients, ages 18–70, diagnosed with adenocarcinoma of the colon or rectum that has not spread beyond the local lymph nodes. Patients should not have problems with any other organ function and good health otherwise.
Patients cannot take part in this trial if they have been diagnosed with a distant metastasis (cancer that has spread to another area of the body), intestinal obstruction, or prior cancer treated with chemotherapy or radiation. Females must not be pregnant or breastfeeding. Patients with uncontrolled hypertension (high blood pressure) or significant cardiovascular disease cannot take part in the trial.
How will it work
All patients will receive a combination of chemotherapy, radiation, and bevacizumab prior to surgical removal of the tumor. Treatment begins with 8 cycles (3 weeks each) of Xelox [a chemotherapy regimen consisting of capecitabine (Xeloda) and oxaliplatin (Eloxatin)] and bevacizumab. Following 8 cycles, patients will undergo 5 weeks of radiation therapy, followed by 2 more cycles of Xelox and bevacizumab.
Six to 7 weeks after the last radiation treatment, patients will have a large part of the bowel surrounding the tumor surgically removed (a total mesorectal excision). Three to 4 weeks following surgery, patients will undergo 3 more cycles of Xelox, followed by 2 cycles of capecitabine alone.
