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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer

NCT03280407

Colorectal Neoplasm Colorectal Cancer Rectal Neoplasms +4 more

UNKNOWN PHASE2

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

NCT05378919

Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

RECRUITING PHASE2

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

NCT00069121

Colorectal Cancer

COMPLETED PHASE3

Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

NCT04303429

Stage II Colon Cancer Adjuvant Chemotherapy

UNKNOWN PHASE3

Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

NCT00112918

Colorectal Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A, Conventional treatment

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

Group Type OTHER

Capecitabine

Intervention Type DRUG

Orally on days 1-14: 2000 mg/m2/day q3w

Oxaliplatin

Intervention Type DRUG

Intravenously on day 1: 130 mg/m2 q3w

B, Neoadjuvant chemotherapy

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

Group Type OTHER

Capecitabine

Intervention Type DRUG

Orally on days 1-14: 2000 mg/m2/day q3w

Oxaliplatin

Intervention Type DRUG

Intravenously on day 1: 130 mg/m2 q3w

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Capecitabine

Orally on days 1-14: 2000 mg/m2/day q3w

Intervention Type DRUG

Oxaliplatin

Intravenously on day 1: 130 mg/m2 q3w

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No