Efficacy of the Use of Neoadjuvant With/without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

Launched by MAIMÓNIDES BIOMEDICAL RESEARCH INSTITUTE OF CÓRDOBA · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new treatment options for patients with locally advanced colon cancer. The main goal is to see if a combination of chemotherapy given before surgery (called neoadjuvant treatment) with or without a special type of heated chemotherapy during surgery can help patients live longer without the cancer coming back, compared to the standard treatment, which includes surgery followed by more chemotherapy. The trial will involve around 1,083 patients who have specific types of colon cancer that haven't spread to other parts of the body.

To participate in this trial, patients need to be between 18 and 75 years old and have certain types of colon cancer that can be surgically removed. They should not have any metastases (cancer spread) and must meet other health criteria. Those who join the trial can expect to receive either the standard treatment or one of the new treatment strategies, and all participants will be monitored for their recovery and any side effects. This study aims to find better ways to treat colon cancer and improve outcomes for patients, which could lead to significant benefits for many individuals facing this disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of both sexes, aged ≥18 years and ≤75 years (patients between 70-75 years old will be discussed in committee).
• • Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eight edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included.
• • Nodal extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pre-treatment diagnosis by imaging test (CT scan or MRI).
• • Metastatic extension: cM0. Patients with cM1 are not allowed to be included.
• • ECOG 0-1.
• • Microsatellite stability (pMMR).
• • Informed consent duty completed.
• Exclusion Criteria:
• • Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage.
• • Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons.
• • Presence of microsatellite instability (dMMR).
• • Presence of deficit of DPD.
• • Urgent intervention due to obstruction or perforation if the primary tumour is removed. Bridge interventions such as transit shunts without removal of the primary tumour or percutaneous drainage of collections prior to neoadjuvant treatment or scheduled surgery will be accepted.
• • Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy).
• • Coexistence of another relevant malignant neoplastic disease (synchronous colon and rectum-sigmoid tumours are accepted as long as the stage is equal or lower than the treated tumour), it will be discussed in steering committee.
• • Severely impaired hepatic, renal or cardiovascular function.
• • Intolerance to treatment.
• • Gestational or lactating women.