Ongoing Clinical Trials for Recurrent Rectal Cancer

There is currently 1 ongoing clinical trial for patients with recurrent rectal cancer. This trial is investigating the use of induction chemotherapy followed by chemoradiotherapy to improve surgical outcomes in patients with locally recurrent disease. The study is being conducted across multiple European countries including the Netherlands, Belgium, Portugal, Sweden, and Norway.

Clinical trial locations

• Belgium
  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer
• Netherlands
  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer
• Norway
  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer
• Portugal
  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer
• Sweden
  • Study Comparing Chemotherapy with Irinotecan, Folinic Acid, and Oxaliplatin for Patients with Locally Recurrent Rectal Cancer

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

This study is exploring different treatment approaches for locally recurrent rectal cancer, which means the cancer has returned in the rectum area after initial treatment. The trial compares two treatment strategies: one group receives a combination of chemotherapy drugs before undergoing chemoradiotherapy, while the other group receives chemoradiotherapy alone.

Main inclusion criteria:

• Patients must be at least 18 years old
• Must have confirmed locally recurrent rectal cancer, either through laboratory testing or clinical evidence including imaging tests
• The cancer must be removable by surgery, as determined by MRI imaging or after chemoradiotherapy treatment
• Must have a WHO performance score of 0-1, meaning patients should be able to perform daily activities with little to no restriction
• Must provide written informed consent to participate

Main exclusion criteria:

• Patients with other types of cancer besides locally recurrent rectal cancer
• Patients who belong to vulnerable populations unable to give informed consent
• Those with medical conditions or taking medications that could interfere with study results
• Pregnant or breastfeeding patients
• Patients who have recently participated in another clinical trial
• Those with severe or uncontrolled health issues that could affect their safety or study outcomes

Focus and goal: The primary goal of this study is to compare the effectiveness of these two treatment approaches in achieving clear resection margins during surgery. Clear margins mean that the cancer is completely removed without any cancer cells remaining at the edges of the removed tissue. The study will carefully monitor participants throughout their treatment journey, tracking their response to the treatments and any side effects they experience. Regular assessments, including imaging tests like MRI, will be conducted to evaluate how well the cancer responds to treatment.

Investigational drugs: The study uses several chemotherapy medications including Irinotecan Hydrochloride, Calcium Folinate (also known as Folinic Acid), Teysuno (which contains Tegafur, Gimeracil, and Oteracil), Oxaliplatin, Fluorouracil, and Xeloda (which contains Capecitabine). These drugs can be given through intravenous infusion or as oral tablets. The chemotherapy works by interfering with cancer cell DNA, preventing the cells from growing and dividing. When combined with radiation therapy in the chemoradiotherapy approach, the chemotherapy makes cancer cells more sensitive to radiation, enhancing the overall treatment effect.

Participants randomly assigned to the induction chemotherapy group will receive these medications over a period of time before starting chemoradiotherapy. After completing the treatment, patients will undergo surgical evaluation to determine if the cancer can be successfully removed. Following surgery, patients will have regular follow-up appointments to monitor their recovery and check for any signs of cancer returning.

Summary

Currently, there is one active clinical trial available for patients with recurrent rectal cancer. This trial represents an important research effort spanning five European countries: the Netherlands, Belgium, Portugal, Sweden, and Norway. The study focuses on optimizing treatment before surgery by testing whether adding induction chemotherapy to the standard chemoradiotherapy approach can improve surgical outcomes.

The trial uses a combination of well-established chemotherapy drugs, including Irinotecan, Oxaliplatin, Fluorouracil, and related medications, administered in different forms. This multi-country collaboration allows researchers to gather comprehensive data on the effectiveness of this treatment strategy in achieving complete cancer removal during surgery, which is a critical factor for long-term patient outcomes.