Prognostic Impact of Tumor Growth Velocity in Head and Neck Squamous Cell Carcinoma Treated by Radio(Chemo)Therapy (TGV-PI)

October 1, 2019 updated by: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

The purpose of this study is to determine the impact of tumor growth velocity on the survival of patients with hea and neck squamous cell carcinoma treated by (chemo-)radiotherapy.

Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume and number and size of pathological neck lymph nodes (small diameter > 1 cm) will be assessed on diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas technique. Tumor progression and tumor doubling time will be calculated based on DiCT and RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67 immunohistochemistry and mitotic index. HPV status will be evaluated by PCR and p16 immunohistochemistry. Ulcerative or exophytic aspect will be noticed. Tumoral kinetics patterns will be correlated with disease free survival and overall survival of patients with HNSCC. These patterns will be compared to HPV status and proliferation markers in order to study their clinical signification [time frame: 5 years] and develop predictive markers of tumor progression for head and neck cancers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Head and neck squamous cell carcinoma (HNSCC) represents more than 90 percent of head and neck tumors and is one of the most frequent human neoplasms. During the last decades, radiotherapy has emerged as a standard treatment of HNSCC and the number of patients treated with this modality has continuously increased. Moreover, treatment schedules for radiotherapy have improved and require more preparation and are therefore more time consuming. Thus, waiting time prior to radiotherapy becomes a major concern in many countries with reported delays of 70 days or even more.Clinicians involved in treating HNSCC face the problem of rapidly growing tumors but despite significant progress in the understanding of these tumors, their development and progression remain currently unpredictible at the time of diagnosis. In a retrospective trial, Laccourreye et al. studied the time of progression of symptoms and signs (TPSS) before diagnosis and treatment in 966 HNSCC cases and showed that for a given tumor stage, the longer was the TPSS, the better were the vital prognosis, the local and lymph node control. But there is no clear definition of fast growing tumor, with objective measurement.

A CT-scan is perfomed at the time of diagnosis. Several weeks later, a second CT-scan is necessary for treatment planning in order to define the tumoral target volume. This necessity provides the opportunity to compare tumoral volumes on both exams, and thus to assess tumoral progression. In a pilot study conducted with Institut Gustave Roussy, the investigators studied retrospectively the tumor and loco-regional progression in the waiting time between diagnostic and treatment planning CT-scans in a cohort of patients with oropharyngeal squamous cell carcinoma, treated by radio(chemo)therapy between April 2005 and April 2007. The study demonstrated that 53% of the patients presented a tumoral progression of > 50% within a mean waiting time of 42.1 +/- 15.7 days. The investigators consider this situation as regrettable, and prospective trials are clearly needed to determine clinical consequences of these findings.

The current project aims to study prospectively the loco-regional tumoral progression within the waiting time between diagnostic and treatment planning CT-scans in a cohort of patients with OPSCC. Patients with oropharyngeal primary squamous cell carcinoma elected for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume, number and size of pathological cervical lymph nodes (small diameter > 1 cm) will be assessed on diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas technique (computerized delineation). Tumoral progression and tumor doubling time will be calculated based on DiCT and RtCT in order to define different tumoral kinetics patterns. Human papillomavirus (HPV) status will be assessed by polymerase chain reaction (PCR) and p16 immunohistochemistry. As primary objective, the investigators will study the tumoral kinetics patterns with disease free survival (DFS) and overall survival (OS) in patients with OPSCC in order to study their clinical signification [time frame: 5 years]. As secondary objectives, the investigators will correlate the tumoral kinetics patterns with HPV status of patients with OPSCC, and compare tumoural kinetics to proliferation markers (Ki67, mitotic index) in order to develop predictive markers of tumour progression for head and neck cancers. An other complementary objective will compare tumor kinetics patterns with endoscopic aspect (ulcerative versus exophytic)

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
        • Contact:
          • Jean-Francois Daisne, MD,PhD
          • Phone Number: +32.81.720.757
      • Yvoir, Belgium, 5530
        • CHU Dinant Godinne
        • Contact:
        • Sub-Investigator:
          • Gilles Delahaut, MD
        • Principal Investigator:
          • Sebastien Van der Vorst, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All T1 to T4 patients under eligibility criteria with head and neck squamous cell carcinoma admitted to the investigators' tertiary centers will be selected.

Centre hospitalier Universitaire Godinne is a belgian provincial tertiary center.

Description

Inclusion Criteria:

  • clinical and anatomopathological diagnosis of a head and neck squamous cell carcinoma (T1 to T4) (oral cavity, oropharynx, larynx, hypopharynx)
  • multidisciplinary decision for radiotherapy or concomitant radiochemotherapy eligibility

Exclusion Criteria:

  • metastatic disease
  • primary surgical management
  • contraindications to iodine contrast injection: anaphylaxis and renal insufficiency
  • tumor not visible on CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
head and neck squamous cell carcinoma
Patients with T1 to T4 head and neck squamous cell carcinoma from oral cavity, oropharynx, larynx and hypopharynx eligible for radiotherapy or concomitant chemoradiotherapy
Other: Tumor delineation
Measurement of tumor volume and neck nodes volume on a diagnostic CT and a pre-treatment CT by computerized delineation in order to calculate tumor growth velocity and tumor doubling time and describe tumoral kinetics patterns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 5 years
5 years
overall survival
Time Frame: 5 years follow-up after recruitment
5 years follow-up after recruitment

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation between kinetics patterns and HPV status
Time Frame: 5y follow-up
5y follow-up

Other Outcome Measures

Outcome Measure
Time Frame
correlation between kinetics patterns and proliferation markers
Time Frame: 5y follow-up
5y follow-up
correlation between kinetics patterns and endoscopic aspect of the tumor
Time Frame: 5y follow-up
5y follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Investigators

  • Principal Investigator: Sebastien Van der Vorst, MD, PhD, CHU Dinant Godinne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGV-PI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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