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

NCT04201002 | Completed

• 1 other identifier: HPCastellon
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Squamous Cell Carcinoma; Pilonidal; Cyst, Malignant; Surgery

Keywords

Pilonidal sinus; Squamous cell carcinoma; Surgery; Intraoperative radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Decrease in recurrence rate

  Squamous cell carcinoma has a high recurrence rate, with surgery plus intraoperative radiotherapy we think it could decrease that recurrence rate.

  1 year

Interventions

Resection plus intraoperative radiotherapy PROCEDURE

En-bloc resection plus intraoperative radiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Squamous cell carcinoma over pilonidal disease

You may not qualify if:

• Distant Metastases

Sponsors & Collaborators

• Hospital Provincial de Castellon: lead

Study Sites (2)

Hospital Provincial Castellon

Castellon, Castellon, 12002, Spain

Location

Hospital Provincial Castellon

Castellon, Spain

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Cysts; Pilonidal Sinus

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Araceli Mayol Oltra

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 16, 2019
• Study Start: February 1, 2019
• Primary Completion: October 11, 2019
• Study Completion: November 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)