Recurrent Head and Neck Cancer Clinical Trial
— RECUTOfficial title:
Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
NCT number | NCT04673929 |
Other study ID # | CCR5156 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 14, 2020 |
Est. completion date | October 1, 2021 |
Verified date | October 2021 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged over 18 - Previous HNC treated with radiotherapy - Undergoing TORS as part of their management for recurrent disease - Surgery performed on or before July 31st 2018. Exclusion Criteria: - TORS used in a diagnostic setting only - Nasopharyngeal and thyroid cancers |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Head and Neck Unit, Royal Marsden Hospital | London | Greater London |
United Kingdom | Royal Marsden Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Chuang SC, Scelo G, Tonita JM, Tamaro S, Jonasson JG, Kliewer EV, Hemminki K, Weiderpass E, Pukkala E, Tracey E, Friis S, Pompe-Kirn V, Brewster DH, Martos C, Chia KS, Boffetta P, Brennan P, Hashibe M. Risk of second primary cancer among patients with head and neck cancers: A pooled analysis of 13 cancer registries. Int J Cancer. 2008 Nov 15;123(10):2390-6. doi: 10.1002/ijc.23798. — View Citation
Dabas S, Dewan A, Ranjan R, Dewan AK, Shukla H, Sinha R. Salvage Transoral Robotic Surgery for Recurrent or Residual Head and Neck Squamous Cell Carcinoma: A Single Institution Experience. Asian Pac J Cancer Prev. 2015;16(17):7627-32. — View Citation
Gross ND, Hanna EY. The Role of Surgery in the Management of Recurrent Oropharyngeal Cancer. Recent Results Cancer Res. 2017;206:197-205. Review. — View Citation
Hamilton D, Paleri V. Role of transoral robotic surgery in current head & neck practice. Surgeon. 2017 Jun;15(3):147-154. doi: 10.1016/j.surge.2016.09.004. Epub 2016 Oct 11. Review. — View Citation
ICMJE | Recommendations | Defining the Role of Authors and Contributors [Internet]. [cited 2019 Jan 23];Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
INTEGRATE (The National ENT Trainee Research Network). British Association of Head and Neck Oncologists Surveillance audit 2018. Unpublished
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation
Microsoft. Excel for Mac [Internet]. Redmond, Washington, USA: Microsoft Corporation; 2018. Available from: https://products.office.com/
Paleri V, Fox H, Coward S, Ragbir M, McQueen A, Ahmed O, Meikle D, Saleh D, O'Hara J, Robinson M. Transoral robotic surgery for residual and recurrent oropharyngeal cancers: Exploratory study of surgical innovation using the IDEAL framework for early-phase surgical studies. Head Neck. 2018 Mar;40(3):512-525. doi: 10.1002/hed.25032. Epub 2017 Dec 15. — View Citation
Paleri V, Wight RG. Applicability of the adult comorbidity evaluation - 27 and the Charlson indexes to assess comorbidity by notes extraction in a cohort of United Kingdom patients with head and neck cancer: a retrospective study. J Laryngol Otol. 2002 Mar;116(3):200-5. — View Citation
Piccirillo JF. Importance of comorbidity in head and neck cancer. Laryngoscope. 2000 Apr;110(4):593-602. — View Citation
R Core Team. R: A language and environment for statistical computing [Internet]. Vienna, Austria: R Foundation for Statistical Computing; 2013. Available from: http://www.R-project.org/
RStudio Team. RStudio: Integrated Development Environment for R [Internet]. Boston, MA: RStudio, Inc.; 2015. Available from: http://www.rstudio.com/
Shield KD, Ferlay J, Jemal A, Sankaranarayanan R, Chaturvedi AK, Bray F, Soerjomataram I. The global incidence of lip, oral cavity, and pharyngeal cancers by subsite in 2012. CA Cancer J Clin. 2017 Jan;67(1):51-64. doi: 10.3322/caac.21384. Epub 2016 Oct 19. — View Citation
Weinstein GS, O'Malley BW Jr, Cohen MA, Quon H. Transoral robotic surgery for advanced oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Nov;136(11):1079-85. doi: 10.1001/archoto.2010.191. — View Citation
White H, Ford S, Bush B, Holsinger FC, Moore E, Ghanem T, Carroll W, Rosenthal E, Sweeny L, Magnuson JS. Salvage surgery for recurrent cancers of the oropharynx: comparing TORS with standard open surgical approaches. JAMA Otolaryngol Head Neck Surg. 2013 Aug 1;139(8):773-8. doi: 10.1001/jamaoto.2013.3866. Erratum in: JAMA Otolaryngol Head Neck Surg.n 2013 Dec;139(12):1290. Sweeny, Larissa [added]. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival at 2 years | Disease-free survival at 2 years | 24 months | |
Secondary | Overall survival at 2 years | Overall survival at 2 years | 24 months | |
Secondary | Disease-specific survival at 2 years | Disease-specific survival at 2 years | 24 months | |
Secondary | Rate of gastrostomy use at 1 year | Rate of gastrostomy use at 1 year | 12 months | |
Secondary | Rate of tracheostomy use at 1 year | Rate of tracheostomy use at 1 year | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05738187 -
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
|
N/A | |
Recruiting |
NCT02567383 -
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
|
Phase 2 | |
Recruiting |
NCT05980000 -
Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03691714 -
Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Terminated |
NCT02842125 -
Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT04969861 -
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04260126 -
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
|
Phase 2 | |
Completed |
NCT02358031 -
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
|
Phase 3 | |
Completed |
NCT02422979 -
Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04902027 -
A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers
|
Phase 1 | |
Recruiting |
NCT04534205 -
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
|
Phase 2 | |
Active, not recruiting |
NCT02289209 -
Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck
|
Phase 2 | |
Recruiting |
NCT06239220 -
PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
|
Phase 2 | |
Recruiting |
NCT03754933 -
Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT03937141 -
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer
|
Phase 2 | |
Terminated |
NCT00088907 -
Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer
|
Phase 3 | |
Terminated |
NCT01606566 -
A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer.
|
Phase 2 | |
Completed |
NCT01620242 -
A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes
|
Phase 2 | |
Completed |
NCT01255800 -
Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer
|
Phase 1 |