Clinical trial NCT02047201: Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Official title: Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck cancer
PET/CT
induction chemotherapy
IMRT
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 24 months after treatment
Secondary outcomes:
measure: Tumour metabolic response (MTV) reduction (%)
timeFrame: 2 weeks after IC
measure: Total lesion glycolysis (TLG) reduction (%)
timeFrame: 2 weeks after IC
measure: SUVmax reductions (%)
timeFrame: 2 weeks after IC
measure: Number (%) of participants with adverse events
timeFrame: 12 and 24 months from chemoradiotherapy
measure: Overall survival (OS)
timeFrame: 24 months after treatment
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Ilona Kulakiene, Prof.
role: PRINCIPAL_INVESTIGATOR
References: