PET on Surgery for Loco-regionally Recurrent Colorectal Cancer

Impact of Positron-Emission-Tomography on the Surgical Treatment for Loco-regionally Recurrent Colorectal Cancer

The influence of Positron-Emission-Tomography (PET) on the surgical treatment of loco-regionally recurrent colorectal cancer (LRRCRC) remains obscure and deserves further investigation.

Study Overview

• Status: Completed
• Conditions: PET-driven Surgery; Loco-regional Recurrent Colorectal Cancer
• Intervention / Treatment: Procedure: Curative intent surgery

Detailed Description

Loco-regionally recurrent colorectal cancer (LRRCRC) occurs in 4.0-11.5% of patients following treatment of primary colorectal cancer with curative intent, and can be categorized as peri-anastomotic, mesenteric/paracolic (nodal), retroperitoneal and peritoneal.1-4 In contrast to distant recurrences (e.g. liver, lung or bone metastasis), LRRCRCs is a less recognized clinical entity, although it is generally accepted that surgical resection remains the major treatment modality to provide the long-term survival for such patients.5-7 However, the value of resection for LRRCRC is obscure, given the role of surgical resection in treating LRRCRC has received comparatively little attention with a scant literature to draw upon when making treatment recommendations and no available consensus statements.8,9 Moreover, in clinical practice, it has been recognized that more than 50% of patients with recurrent colorectal cancer brought to the operating room for attempted curative surgery were unable to undergo the planned operation because more extensive disease than anticipated was discovered at laparotomy. Therefore, it has been suggested that a formal multidisciplinary team (MDT) discussion based on more precise diagnostic armamentariums be mandatory for more accurate evaluation of tumor burden and would allow curative surgery to be offered to a better-selected group of patients with recurrent colorectal malignancy10-14.

Remarkably, Positron-Emission-Tomography (PET) scans are now being widely used for the surveillance of patients having undergone curative resection for the primary colorectal cancer . Whole-body PET scanning in the patient with recurrent colorectal cancer has been reported to be more sensitive and accurate than Computed-Tomography (CT) and Magnetic-Resonance-Imaging (MRI). Moreover, PET is purported to be capable of differentiating among recurrent malignancy, scar, fibrosis, and necrosis, thus preventing the patients from futile surgery.15 With the above-mentioned reasons in mind, we then conducted this retrospective study to look at the efficacy of PET scan for directing surgery in patients with LRRCRC. We hypothesized that with the better diagnostic sensitivity and specificity, as compared to the conventional imaging methods (CT/MRI) in detecting recurrences of colorectal cancer, PET can positively affect the surgical decision-making and thus improve the treatment outcomes for patients with LRRCRCs.

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 308
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

These patients were further grouped into PET-driven vs CT/MRI/PET-driven vs non-surgery group

Description

Inclusion Criteria:

i. patients with primary colorectal cancers undergoing R0 resection ii. Patients with final histopathologic reports documenting the pathologic Tumor-Node-Metastasis (pTNM) stage I, II, or III

Exclusion Criteria:

i. Patients with pTNM stage IV primary colorectal cancer ii. Patients with R1/2 resection

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sole PET group; Tumor recurrence was detected solely by PET; the surgery was performed and the extent of the resection was guided by the PET.	Procedure: Curative intent surgery; Curative intent surgery means that surgeons intend to perform R0 resection.
Combined CT/MRI plus PET group; Tumor recurrence was detected by computed tomography (CT) / magnetic resonance imaging (MRI) and PET; the surgery was performed and the extent of the resection was guided by the CT/MRI+PET.	Procedure: Curative intent surgery; Curative intent surgery means that surgeons intend to perform R0 resection.
Control group; Tumor recurrence was detected but no surgery was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	5-year overall survival	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life expectancy	Median survival	10 year
Type of resection	Sham operation vs R0 vs R1 vs R2	10 year
Blood loss	recorded in mL	10 year
Operation time	recorded in minute	10 year
Type of surgical complication	specific complications; Clavien-Dindo classification	10 year
Hospitalization	recorded in day	10 year
Readmission	within 30 days	10 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Jin-Tung LIANG, MD,PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: 202305096RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No