The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial

Trials
Chang Woo KimSeung Hyuk Baik

Abstract

Approximately 20 % of all patients with colorectal cancer are diagnosed as having Stage IV cancer; 80 % of these present with unresectable metastatic lesions. It is controversial whether chemotherapy with or without primary tumor resection (PTR) is effective for the treatment of patients with colorectal cancer with unresectable metastasis. Primary tumor resection could prevent tumor-related complications such as intestinal obstruction, perforation, bleeding, or fistula. Moreover, it may be associated with an increase in overall survival. However, surgery delays the use of systemic chemotherapy and affects the systemic spread of malignancy. Patients with colon and upper rectal cancer patients with asymptomatic, synchronous, unresectable metastasis will be included after screening. They will be randomized and assigned to receive chemotherapy with or without PTR. The primary endpoint measure is 2-year overall survival rate and the secondary endpoint measures are primary tumor-related complications, quality of life, surgery-related morbidity and mortality, interventions with curative intent, chemotherapy-related toxicity, and total cost until death or study closing day. The authors hypothesize that the group receiving PTR following...Continue Reading

References

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Citations

Dec 7, 2016·Nature Reviews. Clinical Oncology·Cornelis J A PuntLouis Vermeulen
Jun 26, 2018·ANZ Journal of Surgery·Joel Wen Liang LauChoon Seng Chong
Dec 13, 2019·Japanese Journal of Clinical Oncology·Konosuke MoritaniUNKNOWN Colorectal Cancer Study Group (CCSG) of Japan Clinical Oncology Group (JCOG)
Jun 5, 2018·Annals of Gastroenterological Surgery·Takeru MatsudaYoshihiro Kakeji
Jun 8, 2021·Annals of Gastroenterological Surgery·Yusuke FujitaUNKNOWN Japan Society of Laparoscopic Colorectal Surgery

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Methods Mentioned

BETA
X-ray

Clinical Trials Mentioned

NCT01978249

Software Mentioned

SPSS
eVelos
R
PASS
SAS

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