NCT02990936

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Nov 2019Nov 2026

First Submitted

Initial submission to the registry

May 28, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
2.9 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

May 28, 2015

Last Update Submit

October 1, 2019

Conditions

Head and Neck Squamous Cell CarcinomaTumor Growth

Keywords

hea and neck squamous cell carcinomatumor growthpredictive markerstumoral kinetics

Outcome Measures

Primary Outcomes (2)

  • overall survival

    5 years follow-up after recruitment

  • disease-free survival

    5 years

Secondary Outcomes (1)

  • correlation between kinetics patterns and HPV status

    5y follow-up

Other Outcomes (2)

  • correlation between kinetics patterns and proliferation markers

    5y follow-up

  • correlation between kinetics patterns and endoscopic aspect of the tumor

    5y follow-up

Study Arms (1)

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

Interventions

Tumor delineationOTHER

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

head and neck squamous cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Ste-Elisabeth

Namur, 5000, Belgium

Location

CHU Dinant Godinne

Yvoir, 5530, Belgium

Location

Related Publications (9)

  • Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.

    PMID: 17237035BACKGROUND

  • Waaijer A, Terhaard CH, Dehnad H, Hordijk GJ, van Leeuwen MS, Raaymakers CP, Lagendijk JJ. Waiting times for radiotherapy: consequences of volume increase for the TCP in oropharyngeal carcinoma. Radiother Oncol. 2003 Mar;66(3):271-6. doi: 10.1016/s0167-8140(03)00036-7.

    PMID: 12742266BACKGROUND

  • Jensen AR, Nellemann HM, Overgaard J. Tumor progression in waiting time for radiotherapy in head and neck cancer. Radiother Oncol. 2007 Jul;84(1):5-10. doi: 10.1016/j.radonc.2007.04.001. Epub 2007 May 9.

    PMID: 17493700BACKGROUND

  • Brouha XD, Op De Coul B, Terhaard CH, Hordijk GJ. Does waiting time for radiotherapy affect local control of T1N0M0 glottic laryngeal carcinoma? Clin Otolaryngol Allied Sci. 2000 Jun;25(3):215-8. doi: 10.1046/j.1365-2273.2000.00347.x.

    PMID: 10944052BACKGROUND

  • De Meerleer GO, Vakaet LA, De Gersem WR, De Wagter C, De Naeyer B, De Neve W. Radiotherapy of prostate cancer with or without intensity modulated beams: a planning comparison. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):639-48. doi: 10.1016/s0360-3016(00)00419-3.

    PMID: 10837946BACKGROUND

  • Mackillop WJ, Zhou Y, Quirt CF. A comparison of delays in the treatment of cancer with radiation in Canada and the United States. Int J Radiat Oncol Biol Phys. 1995 May 15;32(2):531-9. doi: 10.1016/0360-3016(94)00662-5.

    PMID: 7751195BACKGROUND

  • O'Rourke N, Edwards R. Lung cancer treatment waiting times and tumour growth. Clin Oncol (R Coll Radiol). 2000;12(3):141-4. doi: 10.1053/clon.2000.9139.

    PMID: 10942328BACKGROUND

  • Primdahl H, Nielsen AL, Larsen S, Andersen E, Ipsen M, Lajer C, Vestermark LW, Andersen LJ, Hansen HS, Overgaard M, Overgaard J, Grau C; DAHANCA. Changes from 1992 to 2002 in the pretreatment delay for patients with squamous cell carcinoma of larynx or pharynx: a Danish nationwide survey from DAHANCA. Acta Oncol. 2006;45(2):156-61. doi: 10.1080/02841860500423948.

    PMID: 16546860BACKGROUND

  • Robinson D, Massey T, Davies E, Jack RH, Sehgal A, Moller H. Waiting times for radiotherapy: variation over time and between cancer networks in southeast England. Br J Cancer. 2005 Apr 11;92(7):1201-8. doi: 10.1038/sj.bjc.6602463.

    PMID: 15785752BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Oropharynx biopsy

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Sebastien Van der Vorst, MD, PhD

    CHU Dinant Godinne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastien Van der Vorst, MD, PhD

CONTACT

+32 81 423726sebastien.vandervorst@uclouvain.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

December 13, 2016

Study Start

November 1, 2019

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations

BE(2)