Surgery Plus Intraoperative Radiotherapy as Treatment for Squamous Cell Carcinoma Over Pilonidal Disease.

December 13, 2019 updated by: Araceli Mayol Oltra, Hospital Provincial de Castellon

Squamous Cell Carcinoma Over Pilonidal Disease. A New Therapeutic Approach.

Background: Pilonidal sinus is a very common disease. Malignant transformation occurs in 0,1% of patients. The investigators present a case of squamous cell carcinoma arised from recurrent pilonidal disease, managed by multimodal treatment.

Case presentation: The investigators present a 70-year-old man with chronic pilonidal sinus. Inflammation had worsened in previous months and exploration revealed a large ulcerative mass which biopsy showed a squamous cell carcinoma. CT scan and MRI imaging showed tumoral invasion of the coccyx and both gluteus major muscles. Neoadjuvant radiotherapy, chemotherapy as radiosensitizer and surgery with intraoperative radiotherapy was decided in the multidisciplinary tumor committee. Post neoadjuvant therapy MRI showed partial response with a decrease of the mass but persistence of the coccyx infiltration.

Surgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and partial gluteal resection. Intraoperative radiotherapy was administered over the sacrum and in the bed of the coccyx resection. One week later, reconstructive surgery was practiced using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. Histological examination showed no residual tumor. The patient is currently asymptomatic and he has a satisfactory quality of life.

Conclusions: Although squamous cell carcinoma is rare, it must be suspected in patients with recurrent pilonidal disease. Diagnosis is done by histological examination of biopsies. This type of tumors have a high local recurrence rate. The investigators propose a multimodal treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Castellón De La Plana, Spain
        • Hospital Provincial Castellón
    • Castellon
      • Castellón De La Plana, Castellon, Spain, 12002
        • Hospital Provincial Castellón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We describe the diagnosis, treatment and follow-up of a patient with squamous cell carcinoma over pilonidal disease. The aim of the article is present the intraoperative radiotherapy plus en bloc surgery as a treatment in this cases with high recurrence rate.

Description

Inclusion Criteria:

  • Squamous cell carcinoma over pilonidal disease

Exclusion Criteria:

  • Distant Metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in recurrence rate
Time Frame: 1 year
Squamous cell carcinoma has a high recurrence rate, with surgery plus intraoperative radiotherapy we think it could decrease that recurrence rate.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Provincial de Castellon

Investigators

  • Principal Investigator: Araceli Mayol Oltra, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPCastellon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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