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

V

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

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)

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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