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Study of Valproic Acid, Capecitabine, and Radiotherapy for Patients with Low-Moderate Risk Rectal Cancer

Verified siteRegistered drugNo placebo
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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 rectal cancer, specifically in patients with low to moderate risk. The study is investigating the use of two medications, capecitabine and valproic acid, in combination with a treatment called short-course radiotherapy. Capecitabine is a type of chemotherapy that is taken orally, and valproic acid is commonly used as an anticonvulsant, which means it helps control seizures. In this study, these medications are being used as a preoperative treatment, which means they are given before surgery to try to shrink the tumor.

The purpose of the study is to explore whether adding valproic acid or capecitabine to short-course radiotherapy can improve the rate of complete tumor regression, which means the tumor disappears completely, before surgery. The study is divided into two phases. In the first phase, researchers aim to determine the maximum dose of capecitabine that can be given safely, either alone or with valproic acid, during the radiotherapy. The second phase will compare the effects of adding these medications to the radiotherapy to see if they increase the chances of the tumor disappearing completely.

Participants in the study will receive either the combination of medications and radiotherapy or a placebo, followed by surgery. The study will monitor various outcomes, including the control of the cancer, survival rates, and any side effects or complications from the treatment. The goal is to find the best approach to improve treatment outcomes for patients with low to moderate risk rectal cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include a confirmed diagnosis of rectal cancer, specific tumor characteristics, age between 18 and 75, and a performance status that allows participation.

  2. Step 2

    Medication administration

    The study involves the administration of two medications: capecitabine and valproic acid. Both are taken orally.

    The dosage and frequency of these medications are determined during the study. The goal is to find the maximum tolerated dose (MTD) of capecitabine, both alone and in combination with valproic acid.

  3. Step 3

    Short-course radiotherapy

    Participants undergo short-course radiotherapy (SCRT) as part of the treatment plan. This is a preoperative treatment aimed at reducing the tumor size before surgery.

    The combination of radiotherapy with the medications is intended to increase the rate of complete tumor regression.

  4. Step 4

    Surgery

    Following the completion of the medication and radiotherapy regimen, participants undergo surgery to remove the tumor.

    The surgery is planned to be optimal and radical, aiming for complete removal of the cancerous tissue.

  5. Step 5

    Follow-up and evaluation

    After surgery, participants are monitored for local control of the disease, disease-free survival, and overall survival.

    Additional evaluations include assessing the negative margin status, lymph node involvement, and any surgical complications.

    The study also monitors short and long-term side effects and the impact on quality of life.

Who can join the trial?

7 criteria

  • Patients must have a confirmed diagnosis of a type of rectal cancer called adenocarcinoma.
  • The cancer must be in one of the following stages:
    • T2N0: Tumor size and spread stage, located less than 2 cm from the anal verge.
    • T2N1 or T3N0-N1: Tumor size and spread stages, located between 5 cm and 12 cm from the anal verge, with cancer spreading to nearby fat but not more than 1 mm from a specific area called the mesorectal fascia, as seen on an MRI scan.
    • Patients must be between 18 and 75 years old.
    • Patients must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
    • Patients must use effective birth control if there is a chance of pregnancy.
    • Patients must sign a written informed consent form, agreeing to participate in the study.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than low-risk rectal cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had previous treatment that might affect the study results.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have a history of substance abuse or other conditions that might affect their ability to follow the study procedures.
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Investigated drugs

  • Valproic Acid

    is a medication used in this trial to see if it can help improve the effectiveness of short-course radiotherapy in treating rectal cancer. It is being tested to find out if it can increase the rate of complete tumor regression when used before surgery.

  • Capecitabine

    is another medication involved in the trial. It is being used to determine if it can enhance the effects of short-course radiotherapy in patients with rectal cancer. The goal is to see if it can help achieve a higher rate of complete tumor regression before surgery.

What is already known about the treatment

  • Valproic Acid

    Valproic acid is administered orally and is currently being studied in clinical trials for its potential use in treating low-moderate risk rectal cancer. It is primarily known as a medication for epilepsy and bipolar disorder, but in this context, it is being explored for its ability to enhance the effects of radiotherapy. The drug works by inhibiting histone deacetylase, which can lead to increased expression of genes that suppress tumor growth. It is classified as an anticonvulsant and mood stabilizer.

  • Capecitabine

    Capecitabine is taken orally and is an established chemotherapy drug used in the treatment of various cancers, including colorectal cancer. In the context of the clinical trial, it is being evaluated for its effectiveness in combination with radiotherapy for preoperative treatment of low-moderate risk rectal cancer. Capecitabine is a prodrug that is converted into 5-fluorouracil in the body, which interferes with DNA synthesis in cancer cells, leading to cell death. It is classified as an antimetabolite.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can develop into cancer over time. As the disease progresses, the cancerous cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may advance to more extensive stages. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513920-40-00Estimated enrolment120 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

sourced from the EU Clinical Trials Register and site verification

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