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The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colon Cancer, a Randomized Phase III Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Primary Tumour

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Trial Information

The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colon Cancer, a Randomized Phase III Study


Inclusion Criteria:



- Histological proof of colon cancer

- Resectable primary tumour in situ with unresectable distant metastases

- No severe signs or symptoms related to the primary tumour (i.e. severe bleeding,
obstruction, severe abdominal pain) that require immediate surgery or other
symptomatic treatment (e.g. stenting)

- No prior systemic treatment for advanced disease

- Age ≥ 18 years

- WHO performance status 0-2

- Laboratory values obtained ≤ 4 weeks prior to randomization: Adequate bone marrow
function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100 x
109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance,
Cockroft formula, ≥ 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum
transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with
presence of liver metastases)

- Expected adequacy of follow-up

- Written informed consent

- CT scan abdomen and CT thorax/X-thorax performed ≤ 4 weeks prior to randomization

Exclusion Criteria:

- Pregnancy, lactation

- Rectal cancer

- Unresectable primary tumour (i.e. neurovascular encasement, substantial ingrowth in
pancreatic head), or any condition preventing the safety or feasibility of resection
of the primary tumour, i.e. massive ascites or extensive peritoneal disease

- Second primary malignancy within the past 5 years with the exception of adequately
treated in situ carcinoma of any organ or basal cell carcinoma of the skin

- Any medical condition that prevents the safe administration of systemic treatment

- Previous intolerance of fluoropyrimidines, known dihydropyrimidine dehydrogenase
(DPD) deficiency

- Planned radical resection of all metastatic disease

- Uncontrolled hypertension, i.e. values consistently > 150/100 mmHg

- Use of ≥ 3 antihypertensive drugs

- Significant cardiovascular disease < 1 yr before randomization (symptomatic
congestive heart failure, myocardial infarction, unstable angina pectoris, serious
uncontrolled cardiac arrhythmia, cerebro vascular event)

- Chronic active infection

- Concurrent treatment with any other anti-cancer therapy as described per protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Overall survival of the intent-to-treat population

Outcome Time Frame:

Time from randomisation until death

Safety Issue:

No

Principal Investigator

M. Koopman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Utrecht

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

CAIRO4

NCT ID:

NCT01606098

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Colon Cancer
  • Primary Tumour
  • Surgery
  • Chemotherapy
  • Colonic Neoplasms
  • Neoplasm Metastasis

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