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

Vejle Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Colon Cancer

Treatments: Drug: Capecitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01918527

NeoCol

Details and patient eligibility

About

The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.

Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

A, Conventional treatment

Other group

Description:

Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

B, Neoadjuvant chemotherapy

Other group

Description:

3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine