Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC

Lithuanian University of Health Sciences

Status and phase: Completed; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Cisplatin; Radiation: IMRT; Drug: Fluorouracil; Radiation: PET/CT; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02047201

EHNCTE-1309

Details and patient eligibility

About

To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.

Full description

Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT) planning. This prospective, phase II trial assessed the results of patients with locally advanced squamous cell carcinoma of head and neck treatment with IC following by chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged 18 years or over;
• Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);

Exclusion criteria

• Positive serum pregnancy test in women of childbearing potential or breastfeeding;

• Presence of distant metastasis;

• Second primary tumor;

• History of other malignancy within the last 5 years;

• Recurrent head and neck cancer;

• Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;

• Inadequate organ function, evidenced by the following laboratory results:

  1. Absolute neutrophil count <1,500 cells/mm3;
  2. Platelet count <100,000 cells/mm3;
  3. Hemoglobin <9 g/dL;
  4. Total bilirubin greater than the upper limit of normal (ULN);
  5. AST (SGOT) or ALT (SGPT) >1,5 x ULN;
  6. Alkaline phosphatase levels >2,5 x the ULN;
  7. Serum creatinine >2,0 mg/dl or 177 umol/l.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Experimental

Experimental group

Description:

Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).

Treatment:

Drug: Docetaxel

Radiation: PET/CT

Drug: Fluorouracil

Radiation: IMRT

Drug: Cisplatin