Study Comparing FOLFOX Before Surgery to Risk-Adapted Chemotherapy After Surgery for Patients with Locally Advanced Rectal Cancer and Low Risk of Local Failure
This clinical trial is focused on studying treatments for locally advanced rectal cancer, a type of cancer that occurs in the rectum and has spread to nearby tissues but not to distant parts of the body. The study compares two approaches: receiving chemotherapy before surgery or receiving chemotherapy after surgery. The chemotherapy regimen being tested is called FOLFOX, which includes a combination of medications such as Capecitabine, Fluorouracil, Calcium Folinate Pentahydrate, and Oxaliplatin. These medications are known as antineoplastic agents, which means they are used to stop the growth of cancer cells.
The purpose of the study is to determine which treatment approach is more effective in improving disease-free survival, which refers to the length of time patients remain free from cancer after treatment. Participants in the study will be randomly assigned to one of the two treatment groups. Those in the pre-surgery group will receive chemotherapy before undergoing surgery, while those in the post-surgery group will receive chemotherapy after surgery. The study will also include a group receiving a placebo to compare the effects of the actual treatment. The trial will last for a period of up to 12 months, during which participants will be closely monitored for any changes in their condition.
Throughout the study, various aspects will be assessed, including the side effects of the treatments, the success of the surgeries, and the overall quality of life of the participants. The trial aims to provide valuable information on the best timing for chemotherapy in treating locally advanced rectal cancer, potentially leading to improved outcomes for patients with this condition.
1randomization
Upon joining the study, the patient is randomly assigned to one of two groups. This process is called randomization and ensures that each patient has an equal chance of receiving either the preoperative or postoperative treatment.
2preoperative treatment (if applicable)
If assigned to the preoperative treatment group, the patient receives a combination of medications known as FOLFOX. This includes oxaliplatin administered intravenously, fluorouracil administered intravenously, and calcium folinate pentahydrate administered intravenously. The exact dosage and frequency are determined by the medical team based on individual patient needs.
3surgery
After completing the preoperative treatment, or if assigned to the postoperative group, the patient undergoes surgery to remove the rectal cancer. The type of surgery is determined by the surgeon based on the location and size of the tumor.
4postoperative treatment (if applicable)
If assigned to the postoperative treatment group, or if additional treatment is needed after surgery, the patient receives risk-adapted chemotherapy. This may include medications such as capecitabine taken orally. The dosage and duration are tailored to the patient’s specific condition and response to treatment.
5follow-up and monitoring
Throughout the trial, the patient attends regular follow-up appointments to monitor their health and response to treatment. This includes assessments for any side effects, disease progression, and overall well-being. The frequency and type of follow-up are determined by the medical team.
Who Can Join the Study?
Both male and female patients can participate.
Must have a confirmed diagnosis of rectal adenocarcinoma, which is a type of cancer in the rectum.
The cancer should be located between 0 to 16 cm from the anal verge, as measured by a procedure called rigid rectoscopy.
Blood test results must show serum creatinine levels that are 1.5 times or less than the normal upper limit.
Bilirubin levels should be 2.0 mg/dl or less, and other liver enzymes (SGOT-SGPT, AP) should be 3 times or less than the normal upper limit.
The QTc interval, a measure of heart rhythm, should be 440 milliseconds or less.
Participants must provide informed consent, meaning they agree to participate after understanding the study details.
A high-resolution MRI of the pelvis is required for local staging of the cancer.
A transrectal endoscopic ultrasound (EUS) is needed to help determine the stage of the tumor.
Specific MRI criteria must be met based on the tumor’s location in the rectum (lower, middle, or upper third).
A spiral-CT scan of the abdomen and chest is required to ensure there are no distant metastases, which means the cancer hasn’t spread to other parts of the body.
Participants must be at least 18 years old, with no upper age limit.
Must have a WHO/ECOG Performance Status of 0 or 1, indicating they are fully active or have some restrictions but can still perform light work.
Must have adequate blood, liver, kidney, and metabolic function, including:
Leukocytes (white blood cells) of at least 3,000/mm³
ANC (absolute neutrophil count) of at least 2,000/mm³
Platelets of at least 100,000/mm³
Hemoglobin (Hb) greater than 9 g/dl
Who Cannot Join the Study?
Patients who have had previous surgery that was not complete or successful for the primary tumor.
Patients who have had a return of cancer in the same area after previous surgery.
Patients who have been diagnosed with a second type of cancer, either in the colon or elsewhere in the body.
Patients who have cancer that has spread to other parts of the body or is getting worse.
Patients who have passed away from any cause before the study starts.
FOLFOX: This is a combination chemotherapy regimen used to treat colorectal cancer. It includes three main drugs: 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. These medications work together to stop the growth of cancer cells by interfering with their DNA and preventing them from dividing. In this trial, FOLFOX is being used preoperatively, meaning it is given before surgery to shrink the tumor and make it easier to remove.
Locally Advanced Rectal Cancer – This is a stage of rectal cancer where the tumor has grown into or through the wall of the rectum and may have spread to nearby lymph nodes but not to distant body parts. The disease progresses as the cancer cells multiply and invade surrounding tissues, potentially affecting nearby organs. It can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. As the cancer advances, it may cause more severe symptoms and complications, including obstruction of the bowel. The progression of the disease can vary depending on factors like the tumor’s size, location, and the patient’s overall health.
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