Clinical trial NCT00677586: Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis
Official title: Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasm With Metastasis to the Liver
Keywords: rectal neoplasms
liver metastasis
surgery
simultaneous resection
staged resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.

Detailed description: The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Eligibility criteria: Inclusion Criteria:

* age\>=18 and \<= 75 years
* resectable primary rectal tumor
* remnant liver volume \>= 60%
* without other organ metastasis or peritoneum metastasis
* without contradiction of cardiac and pulmonary diseases
* American Society of Anesthesiologists (ASA) class I - II
* Histologically proved rectal adenocarcinoma

Exclusion Criteria:

* age \> 75 years
* unresectable primary rectal tumor
* remnant liver volume \< 60%
* with other organ metastasis or peritoneum metastasis
* with contradiction of cardiac and pulmonary diseases
* Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
* Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
* Multiple colorectal tumors or other schedules needing for synchronous colon surgery
* Co-existent inflammatory bowel disease
* Pregnancy or lactation
* Patients received treatment other than preoperative radio- or chemoradiotherapy

Primary outcomes:
measure: Severe complication rate after resection of primary and metastatic lesions
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Disease free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Post-operative mortality
timeFrame: 90 days after surgery
measure: Cost of hospitalization
timeFrame: 2 months
measure: Complication rate after resection of primary and metastatic lesions
timeFrame: 30 days after surgery
measure: Postoperative hospital stay
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: department of general surgery, zhongshan hospital, fudan university
name: jianmin xu, MD, PHD
role: STUDY_DIRECTOR
References: