Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for locally recurrent rectal cancer, which is a type of cancer that returns in the rectum after initial treatment. The study is comparing two different approaches to treatment. One group of patients will receive a combination of chemotherapy drugs before undergoing chemoradiotherapy, while the other group will receive chemoradiotherapy alone. The chemotherapy drugs being used in this study include Irinotecan Hydrochloride, Calcium Folinate (also known as Folinic Acid), Teysuno (which contains Tegafur, Gimeracil, and Oteracil), Oxaliplatin, Fluorouracil, and Xeloda (which contains Capecitabine).

The purpose of the study is to compare the effectiveness of these two treatment approaches in achieving clear resection margins, which means removing the cancer completely during surgery. Participants in the study will be randomly assigned to one of the two treatment groups. Those in the chemotherapy group will receive the drugs through intravenous infusion or oral tablets over a period of time before starting chemoradiotherapy. The study will monitor the participants’ progress and response to the treatments, as well as any side effects they may experience.

Throughout the study, participants will undergo regular assessments to track their health and the status of their cancer. These assessments may include imaging tests like MRI to evaluate the cancer’s response to treatment. The study aims to provide valuable information on the best approach to treating locally recurrent rectal cancer, potentially improving outcomes for patients with this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

Written informed consent is required to participate in the trial.

2 initial assessment

An initial assessment is conducted to evaluate the current state of the rectal cancer. This may include imaging tests like MRI to determine if the cancer is resectable.

3 induction chemotherapy

If assigned to the induction chemotherapy group, treatment begins with a combination of medications.

Medications include irinotecan hydrochloride trihydrate and oxaliplatin, both administered intravenously as a solution for infusion.

Additional medications such as folinic acid and fluorouracil are given as a solution for injection.

Oral medications include tegafur, gimeracil, oteracil in capsule form and capecitabine in film-coated tablet form.

The specific dosage and frequency are determined by the medical team based on individual patient needs.

4 chemoradiotherapy

Following induction chemotherapy, or as the initial treatment for some, chemoradiotherapy is administered.

This involves a combination of chemotherapy and radiation therapy to target cancer cells more effectively.

5 surgical evaluation

After completing the neoadjuvant treatment, a surgical evaluation is conducted to assess the possibility of resection with clear margins.

The goal is to determine if the cancer can be surgically removed without leaving any remaining tumor.

6 surgery

If deemed resectable, surgery is performed to remove the cancerous tissue.

The success of the surgery is measured by the rate of clear resection margins.

7 postoperative follow-up

Postoperative follow-up includes monitoring for any complications and assessing recovery.

Additional evaluations may include imaging tests and clinical assessments to check for any signs of cancer recurrence.

8 long-term monitoring

Long-term monitoring is conducted to evaluate overall survival, disease-free survival, and quality of life.

Regular check-ups and tests are scheduled to ensure ongoing health and to detect any potential issues early.

Who Can Join the Study?

Must be 18 years or older.
Must have a confirmed case of locally recurrent rectal cancer. This means the cancer has come back in the rectum area after surgery. Confirmation can be through a lab test called histopathology or by clinical evidence, which includes imaging tests and agreement among medical experts.
The cancer must be resectable, meaning it can be removed by surgery. This is determined by a special imaging test called magnetic resonance imaging (MRI) or after treatment with chemoradiotherapy, which is a combination of chemotherapy and radiation therapy. If the cancer is expected to be left behind after surgery or involves certain nerves or bones, it is not considered resectable.
Must have a WHO performance score of 0-1. This is a scale used to measure how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients with other types of cancer besides locally recurrent rectal cancer cannot participate. This means the cancer has come back in the same area after treatment.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population, such as those who might not be able to give informed consent, are not eligible.
Patients who have medical conditions or are taking medications that could interfere with the study results are excluded.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with severe or uncontrolled health issues that could affect their safety or the study outcomes are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Frisius	Heerenveen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Universitair Ziekenhuis Gent	Gent	Belgium
Isala Klinieken Stichting	Zwolle	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Dr. Bernard Verbeeten Instituut Stichting	Tilburg	The Netherlands
Maastro	Maastricht	The Netherlands
Karolinska University Hospital	Solna	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Medical Center Haaglanden	Leidschendam	The Netherlands
Bravis Ziekenhuis	Roosendaal	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Ljllf Uqqgnarvzopf Maygenb Ckepygq (qsrhr	Leiden	The Netherlands
Rfaldehgj Zemdvjjkgp Sactamhvo	Arnhem	The Netherlands
Uhdotvprvarj Mseufwc Cnqbvhr Grdkndcwj	Groningen	The Netherlands
Zplxvtin Rbubvuzhfcmpstxiwo Ihtcmmaky	Vlissingen	The Netherlands
Aylskqjm Dc Rpfpml Zlocqutccr Bujp	Goes	The Netherlands
Rdiycdypenklkausmd Awrkjq	Arnhem	The Netherlands
Rgornaqhpourtqztgb Iirabwntg Fpvinfaht	Leeuwarden	The Netherlands
Svhvramhi Rksgalw Uspalqittf Mvkswpp Cysict	Nijmegen	The Netherlands
Eqszqqp Urbherzntxzg Mulbtts Cynuymj Rsatogyta (ackslig Mkg	Rotterdam	The Netherlands
Spt Ejaiipxys Haqfmxgh Tgccldd	Tilburg	The Netherlands
Axcbbecch Umr	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.11.2020
Norway	Recruiting	01.11.2020
Portugal	Recruiting	01.11.2020
Sweden	Recruiting	01.11.2020
The Netherlands	Recruiting	01.11.2020

Trial locations

Investigated drugs:

Induction Chemotherapy is a treatment used to shrink tumors before the main treatment. In this trial, it is given to patients with locally recurrent rectal cancer to reduce the size of the cancer and make it easier to remove surgically. This approach aims to improve the chances of a successful surgery with clear margins, meaning no cancer cells are left at the edges of the removed tissue.

Chemoradiotherapy combines chemotherapy and radiation therapy to treat cancer. In this trial, it is used as a neoadjuvant treatment, which means it is given before surgery to help shrink the tumor and kill cancer cells. This combination is intended to enhance the effectiveness of the treatment by using the strengths of both chemotherapy and radiation therapy together.

Investigated diseases:

Rectal cancer recurrent

Locally Recurrent Rectal Cancer – This condition occurs when rectal cancer returns after initial treatment, typically in the same area where it first developed. The cancer cells may have survived the initial treatment and started to grow again, leading to a recurrence. As the disease progresses, it can cause symptoms similar to the original cancer, such as changes in bowel habits, rectal bleeding, or discomfort. The recurrence can be challenging to manage due to scar tissue from previous treatments and the proximity to other organs. The progression of the disease may vary, and it can potentially spread to nearby tissues or organs. Understanding the nature of the recurrence is crucial for planning further treatment strategies.

Trial ID:

2024-512526-28-00

Protocol code:

NL73593.100.20

NCT ID:

NCT04389086

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?