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Study on Short-Course Radiotherapy and Chemotherapy with Fluorouracil, Irinotecan, and Oxaliplatin for Patients with Locally Advanced Rectal Cancer

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What is this study about?

This clinical trial is focused on studying a treatment approach for locally advanced rectal cancer. The treatment being tested involves a combination of therapies, starting with a short course of radiotherapy followed by a chemotherapy regimen known as FOLFOXIRI. This chemotherapy regimen includes the drugs Fluorouracil, Irinotecan, Oxaliplatin, and Calcium Levofolinate. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate the effectiveness of this treatment combination in achieving a complete response, meaning the absence of cancer cells in the tissue removed during surgery. Participants in the study will first receive radiotherapy, which uses high-energy rays to target and kill cancer cells. After this, they will undergo several cycles of chemotherapy with the FOLFOXIRI regimen to further reduce the cancer before surgery. The study aims to determine how well this approach works in treating the cancer and to monitor any side effects that may occur during the treatment process.

Throughout the study, participants will be closely monitored by healthcare professionals to assess their response to the treatment and to ensure their safety. The study will also collect information on the overall health and quality of life of the participants, as well as any changes in their condition. This information will help researchers understand the potential benefits and risks of using this treatment approach for locally advanced rectal cancer.

1 joining the study

Upon joining the study, the patient will begin the process of receiving treatment for locally advanced rectal cancer. The study aims to evaluate the effectiveness of a treatment regimen known as FOLFOXIRI, which includes a combination of chemotherapy drugs.

2 short-course radiotherapy

The initial phase of treatment involves a short course of radiotherapy. This is designed to target and reduce the size of the tumor before chemotherapy begins.

3 consolidation chemotherapy

Following radiotherapy, the patient will receive consolidation chemotherapy. This involves the administration of a combination of drugs: fluorouracil, irinotecan, oxaliplatin, and calcium levofolinate. These drugs are given through an intravenous infusion.

The chemotherapy regimen is administered in cycles, with specific dosages and schedules determined by the study protocol. The goal is to further reduce the tumor and prepare for potential surgical intervention.

4 surgical evaluation

After completing the chemotherapy cycles, the patient will undergo an evaluation to determine the response to treatment. This includes assessing whether the tumor can be surgically removed.

5 surgery

If the tumor is deemed operable, surgery will be performed to remove the tumor. The success of the surgery will be evaluated based on the absence of cancer cells in the removed tissue.

6 follow-up and monitoring

Post-surgery, the patient will be monitored for any signs of cancer recurrence and overall health. This includes regular check-ups and assessments to ensure the effectiveness of the treatment and manage any side effects.

Who Can Join the Study?

  • You must provide written informed consent to participate in the study and any related analyses.
  • You should not have a history of invasive rectal cancer, regardless of how long you have been cancer-free.
  • You should not have other types of rectal cancers or colon cancer at the same time.
  • Imaging tests should not show clear involvement of the pelvic side walls.
  • You should have a life expectancy of at least 5 years, not considering the cancer diagnosis.
  • Your blood health should meet certain levels:
    • Absolute neutrophil count (a type of white blood cell) should be at least 1,500 per mm3.
    • Platelet count should be at least 100,000 per mm3.
    • Hemoglobin level (a protein in red blood cells) should be at least 9 g/dL.
  • Your liver health should meet certain levels:
    • Total bilirubin (a substance made by the liver) should be no more than 1.5 times the normal upper limit.
    • Alkaline phosphatase (an enzyme related to the liver) should be no more than 2 times the normal upper limit.
    • AST (an enzyme related to the liver) should be no more than 2 times the normal upper limit.
  • Your kidney health should meet certain levels:
    • Creatinine clearance (a measure of kidney function) should be more than 50 mL/min.
    • Serum creatinine (a waste product in the blood) should be no more than 1.5 times the normal upper limit.
    • You should not have kidney disease that would prevent study treatment or follow-up.
  • If you are a woman who can have children, you must have a negative blood pregnancy test at the screening visit.
  • You and your partner must agree to avoid pregnancy during the trial. This means using effective birth control methods from the screening visit until 180 days after the last dose of chemotherapy. Abstinence is acceptable if it is your usual lifestyle and preferred method of birth control.
  • You must be between 18 and 70 years old.
  • You must be willing and able to follow the study protocol.
  • You must have a confirmed diagnosis of rectal adenocarcinoma, a type of cancer in the rectum.
  • You must have locally advanced rectal cancer, which means the cancer has certain features like:
    • At least 4 positive lymph nodes in a pelvic MRI.
    • Tumor extending to or beyond the mesorectal fascia (a layer of tissue around the rectum).
    • Specific stages of tumor growth (cT4 or cT3, N1).
  • The lower edge of the tumor should be located between 5 and 12 cm from the anal verge, as measured by a pelvic MRI.
  • Your performance status, which measures your ability to perform daily activities, should be 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • You should not have evidence of cancer spread to other parts of the body, as shown by a total body CT scan.
  • You must have available tumor samples from a previous biopsy.
  • The tumor should be able to be removed completely through surgery, including a procedure called pelvic exenteration if necessary.

Who Cannot Join the Study?

  • Patients with other types of cancer besides locally advanced rectal cancer cannot participate. Locally advanced rectal cancer means the cancer is in the rectum and has spread to nearby areas but not to distant parts of the body.
  • Patients who are not in the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not able to provide informed consent cannot participate. This means they must understand the study and agree to take part.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study cannot participate. These conditions are not specified but could include serious heart, lung, or other organ problems.
  • Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Azienda USL Toscana Centro Prato Italy
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
21.09.2021

Trial locations

Investigated drugs:

FOLFOXIRI is a combination chemotherapy regimen used in this trial. It includes three different chemotherapy drugs that work together to treat cancer. This combination is used as a total neoadjuvant therapy, which means it is given before the main treatment to shrink the tumor and improve the chances of a successful outcome. The goal of using FOLFOXIRI in this trial is to help achieve a complete pathologic response, meaning no cancer cells are found in the tissue samples after treatment.

Short-course radiotherapy is a type of radiation treatment that is given over a shorter period of time compared to traditional radiotherapy. In this trial, it is used before the chemotherapy regimen to help reduce the size of the tumor in patients with locally advanced rectal cancer. The aim is to make the cancer more manageable and increase the effectiveness of subsequent treatments.

Locally Advanced Rectal Cancer – This is a type of cancer that occurs in the rectum, which is the last part of the large intestine. In its locally advanced stage, the cancer has spread beyond the inner lining of the rectum but has not yet reached distant organs. It may involve nearby tissues or lymph nodes, making it more challenging to treat. The progression of this cancer can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. As the disease advances, it may cause more severe symptoms and complications. The focus of treatment is often on reducing the tumor size and preventing further spread.

Trial ID:
2024-513297-21-00
Protocol code:
ShorTrip
Trial Phase:
Therapeutic exploratory (Phase II)

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