Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology

NCT01829646 | Recruiting

• 1 other identifier: S54731
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Despite uniform histopathological definition the response of locally advanced squamous cell carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with locoregional recurrences burdening this patient population. The addition of concurrent chemotherapy and the use of altered fractionation schedules has significantly increased locoregional control and overall survival over the last decade however, this has come at the cost of increased acute and late toxicity, preventing further treatment intensification in all patients. If the investigators want to increase the therapeutic index of HNSCC, we need to be able to tailor the treatment more individually to each patient. The project aims at developing a prognostic model for head and neck cancer patients based on the combination of known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging (MRI) obtained before and during treatment. The investigators plan a prospective trial where 120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will be included. Prior to treatment biopsy material will be collected for genetic analysis and before and during treatment functional MRI with diffusion weighted and dynamic contrast enhanced imaging will be performed. All patients will be followed up multidisciplinary afterwards with follow-up of tumor status and toxicity.

Conditions

Head and Neck Cancer

Keywords

DWI; DCE MRI; ADC; FDG PET; Hypoxia; Prognostic and predictive model

Outcome Measures

Primary Outcomes (1)

• To correlate clinical, molecular and radiological predictors with outcome, as defined by locoregional control and disease free survival. In this way we will develop a prognostic/predictive model.

  The predictive model will be instrumental in the individualization of treatment ensuring optimized treatment and avoiding under- and overtreatment.

  4 year time period

Interventions

functional MRI OTHER

Functional MRI on day 22 of the chemoradiotherapy treatment. Parameters of these images will be later on correlated with outcome.

Hypoxia gene expression profile. OTHER

Tumour biopsies will be obtained as part of the staging procedure (standard). On this biopsies we will conduct a hypoxia gene expression profile (15 genes on PCR that can be analyzed individually or as a group through one binary variable). Hypoxia will be a parameter in our prognostic/predictive model.

Functional MRI before start of treatment. OTHER

As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with outcome.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Patients with non-metastatic locally advanced oropharyngeal cancer who will be treated with chemoradiotherapy, as decided after multidisciplinary consultation.
• A karnofsky performance status ≥ 70%
• Gender: Male - Female
• Informed consent obtained, signed and dated before specific protocol procedures

You may not qualify if:

• Prior irradiation to the head and neck region
• Medical contraindications for any of the planned investigations
• Distant metastases
• Pregnant or lactating women
• Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
• Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Flemish League Against Cancer: collaborator

Study Sites (1)

Departement of Radiation Oncology

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Nuyts, PhD, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daan Nevens, MD

CONTACT

0032473583893; daan.nevens@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Clinical staff member

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 11, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

BE (1)