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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201002
• Other study ID #: HPCastellon
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Hospital Provincial de Castellon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 1, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Squamous cell carcinoma over pilonidal disease

Exclusion Criteria:

• Distant Metastases

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Pilonidal; Cyst, Malignant
• Squamous Cell Carcinoma
• Surgery

Intervention

Procedure:
• Resection plus intraoperative radiotherapy
En-bloc resection plus intraoperative radiotherapy

Locations

Country	Name	City	State
Spain	Hospital Provincial Castellon	Castellón De La Plana	Castellon
Spain	Hospital Provincial Castellon	Castellón De La Plana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Provincial de Castellon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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