PET on Surgery for Loco-regionally Recurrent Colorectal Cancer

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05924282
Collaborator
(none)
193
1
155.6
1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
193 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of Positron-Emission-Tomography on the Surgical Treatment for Loco-regionally Recurrent Colorectal Cancer
Actual Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Jun 20, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 5-year overall survival [10 year]

    5-year overall survival

Secondary Outcome Measures

  1. Life expectancy [10 year]

    Median survival

  2. Type of resection [10 year]

    Sham operation vs R0 vs R1 vs R2

  3. Blood loss [10 year]

    recorded in mL

  4. Operation time [10 year]

    recorded in minute

  5. Type of surgical complication [10 year]

    specific complications; Clavien-Dindo classification

  6. Hospitalization [10 year]

    recorded in day

  7. Readmission [10 year]

    within 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. 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:
  1. Patients with pTNM stage IV primary colorectal cancer ii. Patients with R1/2 resection

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 308

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05924282
Other Study ID Numbers:
  • 202305096RINA
First Posted:
Jun 29, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023