Clinical trial · Observational
Prognostic Impact of Tumor Growth Velocity in Head and Neck Squamous Cell Carcinoma Treated by Radio(Chemo)Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tumor Growth | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor delineation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- head and neck squamous cell carcinoma
- description
- Patients with T1 to T4 head and neck squamous cell carcinoma from oral cavity, oropharynx, larynx and hypopharynx eligible for radiotherapy or concomitant chemoradiotherapy
- interventionNames
- Other: Tumor delineation
Primary outcomes (2)
- measure
- overall survival
- timeFrame
- 5 years follow-up after recruitment
- measure
- disease-free survival
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- correlation between kinetics patterns and HPV status
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDJemal 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 17237035
- BACKGROUNDWaaijer 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 12742266
- BACKGROUNDJensen 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 17493700
- BACKGROUNDBrouha 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 10944052
- BACKGROUNDDe 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 10837946
- BACKGROUNDMackillop 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 7751195
- BACKGROUNDO'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 10942328
- 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.