MedTrace Logo

Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas

NCT03480399 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-08-07

No results posted yet for this study

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

Conditions

  • Sarcoma, Soft Tissue
  • Retroperitoneal Neoplasms
  • Surgery
  • Quality of Life
  • Morbidity

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2021-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480399 on ClinicalTrials.gov