Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area (SALVADS-Fluo)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Drug: indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02920216

2016-A00014-47

Details and patient eligibility

About

Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years old

• Head and Neck Squamous Cell Carcinoma confirmed by biopsy

• Non metastatic disease

• Resectable tumour

• Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy

• Haematological constants, liver function and kidney function adapted in the 15 days before inclusion:

  • Haemoglobin ≥ 9 g / dL
  • Polymorphonuclear neutrophils ≥ 1.5 x 10 9
  • Platelet ≥ 100 x 109 / L
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST <3 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum creatinine <110 mmol / L or creatinine clearance> 55 ml / min (method of Cockcroft)
  • Absence of proteinuria

• WHO 0 or 1

• Signed informed consent form

• Patient affiliated to the social security system.

Exclusion criteria

• Patient considered as non eligible for a salvage surgery
• Metastatic disease
• Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
• Pregnant or breastfeeding women

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

eligible patient for a salvage surgery

Experimental group

Treatment:

Drug: indocyanine green