NCT03480399

Brief Summary

No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma (RSTS). In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study. The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term. Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0. Secondary objectives

  • Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure.
  • Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI questionnaires.
  • Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI.
  • Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual interest, Impotence, Dyspareunia.
  • To correlate the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) with the long-term morbidity and quality of life. Eligibility Inclusion criteria
  • Adult patients (age \> 18 years) with primary localized RSTS surgically treated at our institution
  • Written, voluntary, informed consent Exclusion criteria \- Recurrent disease

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

September 7, 2016

Last Update Submit

August 5, 2019

Conditions

Sarcoma, Soft TissueRetroperitoneal NeoplasmsSurgeryQuality of LifeMorbidity

Keywords

retroperitoneal sarcomaquality of lifemorbiditysurgery

Outcome Measures

Primary Outcomes (1)

  • Global Health Status

    Change between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0.

    4 and 12 months postoperatively

Secondary Outcomes (6)

  • Renal failure

    12 months postoperatively

  • DN4 questionnaire for neuropathic pain

    4 and 12 months postoperatively

  • LEFS questionnaire for lower limb function

    4 and 12 months postoperatively

  • BPI questionnaire for chronic pain

    4 and 12 months postoperatively

  • QLC-C30, Functional Scales

    4 and 12 months postoperatively

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary retroperitoneal sarcoma candidated to multivisceral resection

You may qualify if:

  • Adult patients affected by primary retroperitoneal sarcoma and candidated to complete surgery (multivisceral resection)

You may not qualify if:

  • Recurrent Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fiore M, Brunelli C, Miceli R, Manara M, Lenna S, Rampello NN, Callegaro D, Colombo C, Radaelli S, Pasquali S, Caraceni AT, Gronchi A. A Prospective Observational Study of Multivisceral Resection for Retroperitoneal Sarcoma: Clinical and Patient-Reported Outcomes 1 Year After Surgery. Ann Surg Oncol. 2021 Jul;28(7):3904-3916. doi: 10.1245/s10434-020-09307-7. Epub 2020 Nov 11.

    PMID: 33175262DERIVED

MeSH Terms

Conditions

SarcomaRetroperitoneal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsAbdominal NeoplasmsNeoplasms by Site

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

September 7, 2016

First Posted

March 29, 2018

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2021

Last Updated

August 7, 2019

Record last verified: 2019-08