Study of drug combination (capecitabine, fluorouracil, oxaliplatin, calcium folinate) to prevent cancer recurrence in patients with detectable ctDNA after rectal cancer surgery

3 1 1 1

What is this study about?

This clinical trial focuses on patients with rectal cancer who show signs of tumor DNA in their blood after surgery. The study aims to determine if additional treatment after surgery can help prevent the cancer from returning. The treatment being studied combines several anti-cancer medications: capecitabine (taken by mouth), fluorouracil and oxaliplatin (given through a vein), along with calcium folinate which helps enhance the effectiveness of fluorouracil.

The treatment involves a combination of medications commonly used to treat cancer, known as chemotherapy. These drugs work together to destroy any remaining cancer cells that might be present in the body after surgery. The treatment will be given over several months to determine if it can improve the time patients remain free from cancer returning.

During the study, patients will receive the chemotherapy treatment and have regular check-ups to monitor their health. Blood samples will be taken to check for signs of cancer DNA, which can indicate whether the treatment is working. The study will track how long patients remain cancer-free and their overall survival, while also monitoring their quality of life during and after treatment.

1 Initial screening and confirmation

Your eligibility for the study will be verified based on specific criteria, including being at least 18 years old and having a WHO performance score of 0-1

Confirmation of rectal cancer diagnosis through histological examination is required

A blood test will be performed to check for detectable ctDNA (circulating tumor DNA) in your post-surgery blood sample

2 Treatment assignment

You will be assigned to receive adjuvant chemotherapy treatment

The treatment will consist of either CAPOX or FOLFOX chemotherapy regimen

3 Chemotherapy administration – CAPOX option

Capecitabine will be taken by mouth

Oxaliplatin will be administered through intravenous infusion

4 Chemotherapy administration – FOLFOX option

Fluorouracil will be administered through intravenous infusion

Calcium folinate will be administered through intravenous infusion

Oxaliplatin will be administered through intravenous infusion

5 Follow-up period

Regular blood samples will be collected to monitor ctDNA levels

Your overall health status and quality of life will be assessed

Imaging tests will be performed to monitor for any disease recurrence

The study will continue until September 2030

Who Can Join the Study?

  • Must be 18 years or older
  • Must have a WHO performance score of 0-1 (ability to perform daily activities with minimal limitations)
  • Must provide signed informed consent for participation in the PLCRC study, including agreement for additional blood samples and future research
  • Must provide separate informed consent for the REACT trial
  • Must have confirmed rectal cancer through tissue examination, with either:
    • Previous treatment with radiation therapy (with or without chemotherapy), or
    • Cancer that has grown through the bowel wall (T4), or
    • Cancer that has spread to lymph nodes (N+)
  • Must be considered suitable by their doctor to receive combination chemotherapy treatment (either CAPOX or FOLFOX regimens)
  • Must be able to understand and read the Dutch language
  • Must have detectable circulating tumor DNA (ctDNA) in blood sample taken after surgery
  • Must be mentally capable of understanding and following study procedures

Who Cannot Join the Study?

  • History of other cancers within the past 5 years (except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Previous treatment with chemotherapy (treatment using drugs to destroy cancer cells) for rectal cancer
  • Serious heart conditions including heart failure (when heart cannot pump blood effectively) or recent heart attack within 6 months
  • Severe kidney or liver disease that could affect treatment
  • Active infection requiring systemic treatment (medication that affects the whole body)
  • Pregnant or breastfeeding women
  • Known allergic reactions to the study medications
  • Participation in another clinical trial within the past 30 days
  • Mental conditions that could interfere with following study procedures
  • Inability to give informed consent
  • Metastatic disease (cancer that has spread to other parts of the body)
  • Blood disorders that could make chemotherapy unsafe
  • Uncontrolled diabetes (high blood sugar levels)
  • Major surgery planned during the study period (except for the planned cancer surgery)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Dijklander Ziekenhuis Hoorn The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Bernhoven B.V. Uden The Netherlands
Sbrsmqbyb Memtaki Znstzgsbby Groningen The Netherlands
Afaffocg Du Rxvams Zynmofbhtx Bxyh Goes The Netherlands
Aytirknvs Udp Amsterdam The Netherlands
Sdn Ejzjcabqn Hzirpssb Tlcwqih Tilburg The Netherlands
Azjfqfgr zxcbodwvmv Srsvz Sneek The Netherlands
Lqgjd Uszqitxspyos Mykxejj Cytbdju (efrmx Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.09.2024

Trial locations

Based on the provided trial information, which focuses on adjuvant chemotherapy in rectal cancer patients, the typical medications used would be:

FOLFOX is a combination chemotherapy treatment that includes multiple medications working together to kill cancer cells. It’s commonly used as adjuvant therapy after surgery in rectal cancer patients.

Capecitabine is an oral chemotherapy medication that turns into 5-fluorouracil in the body. It works by interfering with cancer cell growth and is often used as adjuvant therapy in rectal cancer treatment.

5-Fluorouracil (also known as 5-FU) is a chemotherapy medication that stops cancer cells from making DNA and RNA, which they need to grow and multiply. It’s a standard treatment option in rectal cancer therapy.

Note: While specific medications aren’t explicitly listed in the source data, these are the standard adjuvant chemotherapy options typically used in rectal cancer treatment when ctDNA (circulating tumor DNA) is detected after surgery.

Investigated diseases:

Rectal Cancer – A disease that begins when cells in the rectum (the last part of the large intestine) start to grow out of control. It typically develops slowly from polyps, which are small growths on the inner lining of the rectum. The disease usually affects the innermost layer of the rectum first, and over time can grow through the rectal wall. Rectal cancer can spread to nearby tissues and lymph nodes, and may eventually reach other parts of the body. The condition often develops without early warning signs, though it may cause changes in bowel habits and rectal bleeding as it progresses.

Trial ID:
2024-517700-12-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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