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Study Comparing Chemotherapy with Docetaxel, Cisplatin, and Fluorouracil to Standard Treatment for Patients with Advanced Anal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called locally advanced anal squamous cell carcinoma. This is a cancer that affects the anal area and has grown to a more advanced stage but has not spread to other parts of the body. The study is comparing two different treatment approaches to see which is more effective. One approach involves a combination of chemotherapy drugs given before radiation therapy, while the other approach uses only the standard radiation therapy. The chemotherapy drugs being studied include capecitabine, cisplatin, docetaxel, mitomycin, and fluorouracil. These drugs are used to kill cancer cells or stop them from growing.

The purpose of the study is to determine if starting treatment with chemotherapy, followed by radiation therapy, is more effective than just using radiation therapy alone. Participants in the study will receive either the combination of chemotherapy and radiation or just the standard radiation therapy. The study will last for a period of time, during which the health of the participants will be closely monitored. The researchers aim to see if the combination treatment helps patients live longer without the cancer coming back or getting worse.

Throughout the study, participants will undergo regular check-ups and tests, such as MRI scans, to monitor the progress of the treatment. The study will also look at other factors, such as overall survival, quality of life, and any side effects experienced by the participants. The goal is to find the best treatment option for people with this type of cancer, helping them to have a better quality of life and improved outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving either the new treatment or the standard treatment.

  2. Step 2

    Induction chemotherapy

    If assigned to the new treatment group, you will receive induction chemotherapy. This involves taking a combination of medications over a period of time.

    The medications include capecitabine (taken orally), cisplatin (given through an intravenous injection), and docetaxel (administered intravenously).

    This phase consists of 4 cycles. Each cycle lasts for a specific period, during which you will receive the medications at set intervals.

  3. Step 3

    Chemoradiotherapy

    After completing the induction chemotherapy, you will undergo chemoradiotherapy. This treatment combines chemotherapy with radiation therapy to target cancer cells more effectively.

    The chemotherapy medications used in this phase include mitomycin and fluorouracil, both administered intravenously.

    The duration and frequency of this treatment will be explained to you by the medical team.

  4. Step 4

    Standard chemoradiotherapy

    If assigned to the standard treatment group, you will receive standard chemoradiotherapy without the initial induction chemotherapy phase.

    This involves the same combination of chemotherapy and radiation therapy as described in the chemoradiotherapy step.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, regular follow-up appointments will be scheduled to monitor your health and the effectiveness of the treatment.

    These appointments may include physical examinations, imaging tests, and discussions about any side effects you may experience.

    The goal is to ensure your safety and to gather information about the treatment's impact on your condition.

Who can join the trial?

7 criteria

  • The patient must have a type of cancer called anal squamous cell carcinoma, confirmed by a test called a biopsy.
  • The cancer must be locally advanced, which means it has grown in the area where it started but has not spread to other parts of the body. Specifically, it should be at Stage T3 or T4 or Stage N1 (a, b, or c) with any T stage (T1 to T4).
  • The patient must be between 18 and 75 years old. If older than 75, they may still qualify if they have a good score on a special health assessment for older adults.
  • The tumor must be measurable using an imaging test called an MRI.
  • The patient must be able to receive both chemotherapy (treatment with cancer-fighting drugs) and radiotherapy (treatment with radiation).
  • The patient should not have any major health problems that would prevent them from receiving the treatment.
  • The patient must have a WHO performance status of less than 2, which means they should be able to carry out all normal activities without assistance.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than locally advanced anal squamous cell carcinoma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are unable to provide informed consent cannot participate.
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Investigated drugs

  • Modified DCF

    is a combination of three chemotherapy drugs used together to treat cancer. This combination includes Docetaxel, Cisplatin, and 5-Fluorouracil. These drugs work by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. In this trial, the modified DCF is used as an induction therapy, which means it is given before the main treatment to help shrink the tumor and make the main treatment more effective.

  • Standard Chemoradiotherapy (CRT)

    is a treatment that combines chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while radiation therapy uses high-energy rays to target and destroy cancer cells. In this trial, standard CRT is used as the main treatment to help control the cancer and prevent it from spreading further.

What is already known about the treatment

Modified DCF (mDCF) – This medication is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating locally advanced anal squamous cell carcinoma, a type of cancer. The main therapeutic use of mDCF is to shrink tumors and improve survival rates in cancer patients. At the molecular level, mDCF works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as a chemotherapy regimen, which is a type of cancer treatment that uses drugs to kill cancer cells.

Investigated diseases

Locally advanced anal squamous cell carcinoma – This is a type of cancer that originates in the squamous cells lining the anal canal. It is considered locally advanced when the cancer has spread beyond the initial site but has not yet metastasized to distant organs. The disease typically progresses through stages, starting with localized growth in the anal region and potentially spreading to nearby lymph nodes. As the cancer advances, it may cause symptoms such as pain, bleeding, or changes in bowel habits. The progression can lead to further local invasion and, if untreated, may eventually spread to other parts of the body. The disease's progression is influenced by factors such as tumor size, depth of invasion, and lymph node involvement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505972-32-00Protocol codePRODIGE85-KANALRADEstimated enrolment310 patientsSponsorFondation Franc.Cancerologie Digestive

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).