Know Cancer

or
forgot password

An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin) [ASCENT]


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin) [ASCENT]


Inclusion Criteria:



Resected primary tumor patients, and patients with primary tumor in situ:

- Adult patients, >/= 18 years of age

- Previously untreated metastatic colorectal cancer and not a candidate for curative
resection

- WHO performance status of 0-1

- Life expectancy of >/= 3 months

- Eligible for XELOX, mFOLFOX6, FOLFIRI and Avastin treatment in accordance with local
standards of care and pharmaceutical benefits scheme

Additional inclusion criteria for patients with primary tumor in situ:

- Intact primary tumor of the colon or the rectum not requiring surgical intervention
prior to study start

- Minimal or asymptomatic primary tumor

Exclusion Criteria:

Resected primary tumor patients, and patients with primary tumor in situ:

- Previous chemotherapy for metastatic colorectal cancer

- Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start

- Radiotherapy within 28 days prior to enrolment or not recovered from a radiotherapy

- History of non-colorectal cancer (patients are eligible if disease-free for more than
5 years and the risk of recurrence is deemed low)

- Presence of active inflammatory bowel disease

- History of gastrointestinal perforations

- Peritoneal disease

- History of significant bleeding event

- Significant vascular disease

- Peripheral arterial thrombosis or other thrombotic event within 6 months before study
start

Additional exclusion criteria for patients with primary tumor in situ:

- Prior endoscopic management of the current tumor

- Acute diverticulitis

- Presence of intra-abdominal abscess

- Active gastroduodenal ulcer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prognostic value of the host inflammatory response as assessed by the neutrophil/lymphocyte ratio on progression-free survival

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Australia: Therapeutic Goods Administration

Study ID:

ML25753

NCT ID:

NCT01588990

Start Date:

June 2012

Completion Date:

August 2016

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location