Study on Temozolomide and Irinotecan for Patients with Stage II/III Colorectal Cancer and Positive ctDNA After Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer known as colorectal cancer, specifically in patients who have a high risk of the disease returning after initial treatment. The study is investigating the use of two medications, Temozolomide and Irinotecan, to see if they can help reduce the risk of cancer coming back. These medications are being tested in patients whose cancer cells have certain characteristics, such as being microsatellite stable and having a silenced gene called MGMT. The trial is called the ERASE-TMZ study.

The purpose of the study is to evaluate how effective the combination of Temozolomide and Irinotecan is in treating patients with this specific type of colorectal cancer. Participants in the study will receive these medications after they have completed standard chemotherapy, which usually includes a drug called oxaliplatin. The study will monitor patients to see if the cancer remains undetectable in their blood tests, which is a sign that the treatment might be working. Some patients will receive a placebo instead of the active medications to compare the results.

Throughout the study, patients will be regularly checked to ensure their safety and to monitor any side effects from the treatment. The study will also look at how long patients remain free of cancer and their overall survival. Additionally, researchers will collect information from patients about their quality of life during the study. This information will help determine if the treatment is not only effective but also tolerable for patients. The study aims to provide valuable insights into whether this combination of medications can be a beneficial treatment option for patients with this type of colorectal cancer.

1 joining the study

Upon joining the study, the patient must have completed radical surgery and at least three months of oxaliplatin-based adjuvant chemotherapy.

The patient must have a confirmed diagnosis of stage III or T4N0 stage II colorectal cancer or locally-advanced resectable rectal cancer.

The patient must have provided written informed consent and meet specific health criteria, including adequate organ function and no evidence of metastatic disease.

2 initial assessment

An initial assessment will be conducted to confirm the presence of circulating tumor DNA (ctDNA) in liquid biopsies collected 2-6 weeks after the last dose of standard adjuvant chemotherapy.

The patient must have absent MGMT expression and MGMT promoter methylation, as well as microsatellite stable (MSS) status.

3 treatment phase

The treatment phase involves the administration of a consolidation regimen with temozolomide and irinotecan (TEMIRI).

Temozolomide is taken orally, while irinotecan is administered via injection.

The specific dosage, frequency, and duration of administration will be determined by the study protocol.

4 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be closely monitored.

Regular assessments will include physical examinations, blood and urine tests, and the collection of patient-reported outcomes using standardized questionnaires.

The primary goal is to measure the rate of seroreversion and ensure the patient remains disease-free for two years.

5 completion of the trial

The trial is expected to conclude by October 2024.

Upon completion, the patient’s overall survival and disease-free survival will be evaluated.

The safety and effectiveness of the TEMIRI regimen will be assessed, and any adverse effects will be documented.

Who Can Join the Study?

Have provided written informed consent before any study-specific procedures.
Have adequate organ function, meaning the organs are working well enough.
Have a carcinoembryonic antigen (CEA) level of 10 ng/ml or less. CEA is a substance in the blood that can be higher in some cancers.
No signs of cancer spreading to other parts of the body, as shown by a chest and abdomen CT scan.
Male participants with female partners who can have children must agree to use effective birth control methods.
Women who can have children must have a negative blood pregnancy test at the start of the study. This includes all women after puberty unless they have not had a period for at least 12 months, have had surgery to prevent pregnancy, or are not sexually active.
Must be at least 18 years old.
Have a confirmed diagnosis of stage III or T4N0 stage II colon cancer or locally-advanced rectal cancer that can be surgically removed.
Have completed major surgery for colon cancer and preoperative chemoradiotherapy and major surgery for rectal cancer.
Have completed at least 3 months of oxaliplatin-based adjuvant chemotherapy, which is additional treatment given after surgery.
Have no MGMT expression, which is a specific protein, and MGMT promoter methylation greater than 5%, as well as MSS, which means the cancer is microsatellite stable.
Have positive circulating tumor DNA (ctDNA) in blood samples taken 2-6 weeks after the last dose of standard adjuvant chemotherapy. ctDNA is a small amount of DNA from cancer cells found in the blood.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means the person is fully active or has some symptoms but can still do light work.
Have completed adjuvant chemotherapy for at least three months.

Who Cannot Join the Study?

Patients who have not completed oxaliplatin-based adjuvant chemotherapy.
Patients without positive circulating tumor DNA (ctDNA) after chemotherapy. Circulating tumor DNA is a small amount of DNA from cancer cells that can be found in the blood.
Patients with colorectal cancer that is not classified as Stage II (pT4) or Stage III.
Patients with colorectal cancer that is not microsatellite stable. Microsatellite stable means the cancer cells do not have a specific type of genetic instability.
Patients whose cancer is not MGMT silenced. MGMT silenced means a specific gene in the cancer cells is turned off, which can affect how the cancer responds to treatment.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, such as those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
ARNAS Garibaldi Di Catania	Catania	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Fondazione Poliambulanza	Brescia	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Ente Ospedaliero Ospedali Galliera Di Genova	Genoa	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda USL Toscana Centro	Prato	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Iwvgsgtl Rhibospmx Pwl Lu Scdsij Drx Tmavfy Dzlq Aclalpx Ifnq Sskjpw	Meldola	Italy
Armeavb Ucu Iiiub Di Rlsqta Ezorft	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.03.2021

Trial locations

Investigated drugs:

Temozolomide is a medication used in this trial to help treat colorectal cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and multiplying. This medication is part of the consolidation therapy aimed at patients who have specific genetic characteristics in their cancer.

Irinotecan is another medication used in the trial. It is a type of chemotherapy that interferes with the DNA of cancer cells, preventing them from dividing and growing. In this study, it is used alongside temozolomide to enhance the treatment’s effectiveness for patients with colorectal cancer who have certain genetic markers.

The combination of these two medications, known as the TEMIRI regimen, is being tested to see if it can help reduce the presence of cancer cells in the blood after patients have already received standard chemotherapy.

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease can progress through various stages, with stage II and III indicating more advanced cancer that may have spread to nearby tissues or lymph nodes. In some cases, circulating tumor DNA (ctDNA) can be detected in the blood, indicating the presence of cancer cells. The progression of colorectal cancer can vary, with some cases remaining localized while others may spread to other parts of the body.

Trial ID:

2024-515681-14-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Temozolomide and Irinotecan for Patients with Stage II/III Colorectal Cancer and Positive ctDNA After Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?