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Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF: Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF: Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial


Inclusion Criteria:



Histology and stages:

- Histologically proven adenocarcinoma in the colon or rectum

- At least 1 measurable metastatic disease manifestation according to the RECIST
criteria (version 1.1)

- Potentially completely resectable or potentially curable metastatic colorectal cancer
as determined by the local MDT conference and that requires tumour shrinkage before
resection is possible. The following definitions are indicative:

- 4 or more liver metastases (CRLeM) without extra-hepatic disease

- 2 or more lung metastases (CRLuM) without hepatic or extra-hepatic disease

- 1 or more CRLeM determined as "potentially resectable" (such as because of
location) by the local MDT.

- 1 or more CRLuM determined by the local MDT as potentially resectable (such as
because of location).

- Non-resectable primary disease with resectable CRLeM or CRLuM.

KRAS and BRAF status:

- Tumour tissue (primary or metastasis) typed as wild-type KRAS AND wild-type BRAF

General conditions:

- age > 18 years

- WHO performance status ≤ 1

- expected survival > 3 months

- sufficient bone-marrow function (Hb ≥ 6.2 µmol/l/Hb > 10 g/dl ANC ≥ 1.5 x 109/l,
thrombocytes ≥ 100 x 109/l)

- sufficient kidney and liver function: total bilirubin ≤ 1.5 x upper normal limit,
serum creatinine ≤ 1.25 x upper normal limit, ALAT ≤ 3 x upper normal limit and ≤ 5 x
upper normal limit with liver metastases

- the patient must have signed an informed declaration of consent before being
registered; this must be documentable according to national guidelines

Exclusion Criteria:

Previous treatment:

- previous chemotherapy for advanced/metastatic disease

- adjuvant chemotherapy unless completed more than 6 months before registration

- previous treatment with oxaliplatin or irinotecan

- previous treatment with cetuximab or other treatment for EGFR

- History of Inflammatory Bowel disease

- Severe or uncontrolled cardiovascular disease, congestive heart failure NYHA III or
IV, unstable angina pectoris, history of myocardial infarction within the last twelve
months, significant arrhythmias)

- Any condition that, according to the treating physician's judgement, could prevent
the planned medical/surgical treatment from being carried out responsibly (such as
uncontrolled active infection, known hypersensitivity or contra-indication for the
planned treatment.

- Pregnant or breast-feeding women

- Patients of fertile age who do not want to use reliable contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Response rate (RR)

Outcome Time Frame:

March 2015 (up to 3 years)

Safety Issue:

Yes

Principal Investigator

Per Pfeiffer, Professor, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

Nordic 8

NCT ID:

NCT01867697

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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