Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Launched by VEJLE HOSPITAL · Aug 6, 2013

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat locally advanced colon cancer. One group of patients will receive three cycles of chemotherapy before their surgery (this is called neoadjuvant chemotherapy), while the other group will have surgery followed by eight cycles of chemotherapy (known as adjuvant chemotherapy). The goal is to see if patients who receive the neoadjuvant treatment can avoid the additional chemotherapy after their surgery, which could save them from going through five extra cycles of treatment.

To participate in this study, patients need to be adults aged 18 or older with a specific type of locally advanced colon cancer confirmed by a CT scan. They also need to meet certain health criteria, like having stable blood counts and no serious heart conditions. Patients involved in the trial can expect close monitoring and support throughout their treatment. This study is currently active but not recruiting new participants. It’s important for potential participants to understand the commitment involved, including the need for informed consent and the requirement for women of childbearing age to use effective contraception during and after the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically verified locally advanced T3 (ETI \> 5 mm) or T4 colon cancer assessed by CT scan.
• • Age ≥ 18 years
• • PS 0-2.
• • Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l.
• • Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value
• • Consent to translational research
• • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
• • Written and orally informed consent.
• Exclusion Criteria:
• • Patients with distant metastases.
• • Acute operation
• • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion.
• • Active, serious infection or other serious disease.
• • Peripheral neuropathy NCI grade \> 1
• • Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
• • Other investigational treatment within 30 days prior to treatment start.
• • Hypersensitivity to one or more of the active or auxiliary substances.