scholarly journals The CAIRO4 Study: The Role of Surgery of the Primary Tumour with Few or Absent Symptoms in Patients with Synchronous Unresectable Metastases of Colorectal Cancer: A Randomized Phase III Study

2014 ◽  
Vol 25 ◽  
pp. ii98 ◽  
Author(s):  
't Lam - Boer Jorine ◽  
Mol Linda ◽  
Verhoef Cornelis ◽  
de Haan Ton ◽  
Punt Cornelis ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumour ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Unresectable Metastases

scholarly journals The CAIRO4 study: The role of surgery of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastases of colorectal cancer—A randomized phase III study of the Dutch Colorectal Cancer Group (DCCG).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS782-TPS782
Author(s):  
Johannes H.W. de Wilt ◽  
Cornelis Verhoef ◽  
Cornelis J. A. Punt ◽  
Jorine HW 't Lam-Boer ◽  
Mette Yilmaz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Systemic Therapy ◽  
Survival Benefit ◽  
Primary Tumour ◽  
Phase Iii ◽  
Surgical Morbidity ◽  
Cancer Group ◽  
Phase Iii Study ◽  
Unresectable Metastases

TPS782 Background: There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease. Retrospective studies also show a potential survival benefit for patients undergoing resection. However, surgery can cause severe morbidity and mortality in this patient group. We hereby propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival. Methods: The CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group (DCCG). Patients with synchronous unresectable metastases of colorectal cancer and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only, and resection of the primary tumour followed by systemic therapy. Patients will be stratified according to location of the primary tumour (colon versus rectum), WHO performance status (0-1 versus 2), hospital of inclusion, serum LDH (normal versus abnormal) and number of metastatic sites (single versus multiple). To demonstrate a survival benefit of 6 months in the experimental arm, a total of 218 events are needed (80% power, significance lever 0.05). Accounting for accrual time and follow-up, we need a total of 360 patients (180 patients per arm). Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab. The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control arm. Accrual has started in September 2012. As of January 2015, 64 centres in the Netherlands and Denmark are participating in the CAIRO4 study. Clinical trial information: NCT01606098.

ATTACHE: A phase III, multicenter, randomized comparison of chemotherapy given prior to and post surgical resection versus chemotherapy given post surgical resection for hepatic metastases from colorectal cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS3643-TPS3643
Author(s):  
Jonathan Fawcett ◽  
Katrin Marie Sjoquist ◽  
Rob Padbury ◽  
Christopher Christophi ◽  
Niall Christopher Tebbutt ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Liver Metastases ◽  
Surgical Resection ◽  
Operative Treatment ◽  
Primary Tumour ◽  
Hepatic Metastases ◽  
Phase Iii ◽  
Treatment Needs

TPS3643 Background: No randomized studies have directly compared the role of peri-operative to adjuvant chemotherapy for resectable liver metastases. Benefit from post operative compared to peri-operative treatment has been suggested in a recent retrospective study of 499 patients with resected colorectal liver metastases which showed improved survival with entirely post-operative chemotherapy. Given this data and that of the small randomised trials demonstrating improved surgical outcomes with adjuvant chemotherapy, the role of entirely post-operative chemotherapy as a means of improving outcomes while reducing the negative effects of pre-operative treatment needs to be examined. Methods: 200 patients randomized 1:1 to 6 months of treatment post-operatively or 3 months of treatment pre-operatively and 3 months post-operatively. Site investigators will nominate chemotherapy schedule (mFOLFOX6, XELOX or FOLFIRI when adjuvant oxaliplatin received previously) prior to randomisation. Primary endpoint: proportion of patients in each arm with surgical complications within 30 days. Secondary endpoints: proportion of patients completing planned chemotherapy, post operative mortality rate (in each group), tolerability and safety of treatment, response rate by RECIST V1.1 and CEA, time to progression, time to treatment failure, overall survival, QoL (EORTC QLQ-C30 and QLQ-LMC21). A planned prospective meta-analysis with MRC (UK) and NSABP C-11 trials will have sufficient power to examine the effect of schedule (peri- or post-operative) on progression free survival (PFS). Eligibility: Patients with histologically proven colorectal cancer with radiologically confirmed, resectable liver metastases without evidence of extra-hepatic disease are eligible. Patients with synchronous metastases who have undergone resection of the primary tumour are eligible but patients requiring combined resection of primary cancer and liver metastatic disease are excluded. Patients with involved hilar nodes or wound implant metastases will not be eligible. Trial Status: Study opened to accrual August 2011.

Surgery of the Primary Tumour in Stage IV Colorectal Cancer with Unresectable Metastases

2012 ◽  
Vol 08 (01) ◽  
pp. 27 ◽  
Author(s):  
Ninos Ayez ◽  
Wijnand J Alberda ◽  
Henk M Verheul ◽  
Jacobus W Burger ◽  
Johannes H de Wilt ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumour ◽  
Stage Iv ◽  
Prophylactic Surgery ◽  
Stage Iv Colorectal Cancer ◽  
Limited Life ◽  
Number Of Patients ◽  
Unresectable Metastases

Since patients with incurable metastatic colorectal cancer (CRC) only have a relatively limited life expectancy, and resection of the primary tumour is accompanied by both morbidity and mortality, it is under debate whether resection of the primary tumour has an effect on survival or quality of life. The rationale behind the resection strategy is that prophylactic surgery prevents future complications. With current new chemotherapy regimens, a relatively low number of patients with metastatic CRC require surgery for their primary tumour. Many studies concerning the management of incurable stage IV CRC have been performed and most studies suggest a survival benefit for patients undergoing surgical resection of the primary tumour compared with those who received palliative treatment. However, in stage IV CRC with unresectable metastases, the role of a palliative resection of the primary tumour has never been assessed properly. Because randomised clinical trials are lacking, it is difficult to draw conclusions from the present literature.

scholarly journals Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer

2009 ◽  
Vol 102 (1) ◽  
pp. 59-67 ◽  
Author(s):  
T Conroy ◽  
M Hebbar ◽  
J Bennouna ◽  
M Ducreux ◽  
M Ychou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study

Ziv-aflibercept: A novel angiogenesis inhibitor for the treatment of metastatic colorectal cancer

2013 ◽  
Vol 70 (21) ◽  
pp. 1887-1896 ◽  
Author(s):  
Clement Chung ◽  
Nisha Pherwani
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Performance Status ◽  
Angiogenesis Inhibitor ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Second Line ◽  
Patient Response ◽  
Line Setting

Abstract Purpose The pharmacology, pharmacokinetics, clinical efficacy, safety, and administration of ziv-aflibercept in combination therapy for metastatic colorectal cancer (mCRC) are reviewed. Summary Ziv-aflibercept (Zaltrap, Regeneron Pharmaceuticals and sanofi-aventis) is a novel recombinant fusion protein that targets the angiogenesis signaling pathway of tumor cells by blocking vascular endothelial growth factor (VEGF) receptors that play a key role in tumor growth and metastasis; it is a more potent VEGF blocker than bevacizumab. Ziv-aflibercept is approved by the Food and Drug Administration for use in combination with fluorouracil, irinotecan, and leucovorin (the FOLFIRI regimen) for second-line treatment of patients with mCRC who have disease progression during first-line oxaliplatin-based chemotherapy. A Phase III trial demonstrated that relative to FOLFIRI therapy alone, the use of ziv-aflibercept was associated with significantly improved patient response, overall survival, and progression-free survival in patients with good performance status at baseline, including some who had received prior bevacizumab therapy. The most common grade 3 or 4 adverse effects associated with ziv-aflibercept use in clinical studies were neutropenia, hypertension, and diarrhea; the U.S. product labeling warns of potential hemorrhage and other treatment-related risks. Conclusion Current clinical data are insufficient to directly compare ziv-aflibercept and bevacizumab when used with standard combination chemotherapy as first- or second-line regimens for mCRC. The role of ziv-aflibercept is currently limited to the second-line setting in combination with irinotecan-based regimens in mCRC patients who have not received irinotecan previously. The role of ziv-aflibercept in chemotherapy for other tumor types is yet to be determined.

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