Study comparing oxaliplatin and irinotecan chemotherapy effectiveness using tumor testing in patients with metastatic colorectal cancer

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What is this study about?

This study focuses on patients with metastatic colorectal cancer, specifically the MSS/pMMR subtype. The research aims to test a new approach using patient-derived tumouroids (laboratory-grown tumor cells) to help doctors choose between two different chemotherapy combinations for treatment. The study compares two treatment options: an oxaliplatin-based therapy and an irinotecan-based therapy, both given through intravenous infusion.

The treatments being studied include two different combinations of chemotherapy drugs. The first combination contains Oxaliplatin Fresenius Kabi as a solution for infusion, which can be given up to 200 mg per square meter of body surface area per day. The second combination contains Irinotecan Fresenius Kabi as a solution for infusion, which can be given up to 400 mg per square meter of body surface area per day. Both treatments may be given for up to 12 months.

During the study, small samples of tumor tissue will be collected and grown in a laboratory to create tumouroids. These laboratory-grown samples will be tested to see how they respond to different chemotherapy combinations. This information will help determine which treatment might work better for each patient. The study will track how well patients respond to treatment, how long the treatment keeps the cancer under control, and any side effects that may occur.

1 Initial treatment evaluation

Your doctor will evaluate if you are eligible for two types of chemotherapy: FOLFOX (oxaliplatin-based) or FOLFIRI (irinotecan-based)

Both treatments must be equally suitable for your specific case of metastatic colorectal cancer

2 Treatment assignment

Based on laboratory analysis of your tumor tissue, you will be assigned to receive either:

Oxaliplatin (Oxaliplatin Fresenius Kabi) through intravenous infusion

or

Irinotecan (Irinotecan Fresenius Kabi) through intravenous infusion

3 Treatment monitoring

Your response to treatment will be regularly monitored using imaging scans

Side effects will be tracked and recorded using standard medical criteria

Your overall health status will be regularly assessed

4 Ongoing evaluation

Your doctor will monitor how well the cancer responds to treatment

Regular checks will be performed to measure if the cancer is stable, shrinking, or growing

Treatment will continue as long as it is providing benefit and side effects are manageable

5 Follow-up period

After treatment completion, regular follow-up visits will be scheduled to monitor your health

The study will track your progress for an extended period to evaluate long-term outcomes

Who Can Join the Study?

  • You must be 18 years of age or older
  • You must be willing and able to provide written informed consent to participate in the study
  • You must have a good level of physical function (ECOG performance status of 0 or 1, meaning you are either fully active or restricted only in strenuous physical activity)
  • You must have confirmed colon or rectal cancer with specific characteristics (pMMR/MSS type) proven by tissue examination
  • Your doctor must determine that two specific chemotherapy treatments (FOLFOX or FOLFIRI, with or without additional antibody therapy) are equally suitable as your first treatment option
  • Your cancer must be metastatic (spread to other parts of the body) and not suitable for complete surgical removal
  • You must have cancer that can be measured or evaluated using standard imaging criteria (RECIST 1.1)
  • You must be able to receive full-strength chemotherapy doses when starting treatment

Who Cannot Join the Study?

  • Previous participation in another clinical trial within the last 30 days
  • Known hypersensitivity (severe allergic reaction) to any of the study medications or their ingredients
  • Presence of any other type of cancer besides metastatic colorectal cancer (cancer that has spread from the colon/rectum to other parts of the body)
  • Severe heart, liver, or kidney disease that is not well controlled
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Pregnancy or breastfeeding
  • Mental conditions that could interfere with following study procedures
  • Unable to provide informed consent
  • History of organ transplantation
  • Any serious medical condition that the study doctor believes could make it unsafe to participate
  • Current substance abuse or alcohol dependency
  • Unable to swallow oral medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway

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

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
15.01.2025

Trial locations

Oxaliplatin is a chemotherapy medication used to treat colorectal cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. This medication is often combined with other drugs to create a more effective treatment for metastatic colorectal cancer.

Irinotecan is another chemotherapy medication used in the treatment of colorectal cancer. It works by blocking an enzyme that cancer cells need to divide and grow. This medication is commonly used when cancer has spread to other parts of the body (metastatic cancer).

Both medications are being compared in this study using patient-derived tumouroids (laboratory-grown mini versions of patient tumors) to help determine which treatment might work better for individual patients with metastatic colorectal cancer.

Investigated diseases:

Metastatic Colorectal Cancer (MSS/pMMR) – A form of colorectal cancer that has spread beyond the original site to other parts of the body, specifically characterized by microsatellite stable (MSS) and proficient mismatch repair (pMMR) status. This type of cancer begins in the colon or rectum and develops when healthy cells in these areas change and grow out of control, forming a mass called a tumor. The MSS/pMMR subtype represents the most common form of colorectal cancer, characterized by stable DNA repair mechanisms. As the disease progresses, cancer cells can break away from the primary tumor and travel through the blood or lymphatic system to form new tumors in other organs, most commonly the liver and lungs.

Trial ID:
2024-517677-25-00
Trial Phase:
Therapeutic exploratory (Phase II)

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