Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT05527782 | Active Not Recruiting Phase 2

• 1 other identifier: HUDP-CyC-01/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

head and neck cancer; induction chemotherapy; modified TPF; concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  percentage of partial and complete response rates (RR)

  12 weeks after radiotherapy termination

Secondary Outcomes (6)

• 24 month progression free survival (PFS)

  2 years

• 24 month overall survival (OS)

  2 years

• toxicity of induction mTPF

  up to 10 weeks

• toxicity of concurrent chemoradiotherapy (CCRT)

  through study completion, an average of 2 years

• EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)

  9 months

Other Outcomes (2)

• treatment compliance according to the protocol

  2 years

• treatment dose modifications and delays

  2 years

Study Arms (1)

induction mTPF

EXPERIMENTAL

1. 4 CYCLES OF INDUCTION mTPF: Docetaxel 40 mg/m2 iv day 1, Cisplatin 40 mg/m2 iv day 1, Leucovorin 400 mg/m2 iv followed by Fluorouracil (5FU) bolus 400 mg/m2 iv day 1, 5FU 1000 mg/m2 iv day 1-2, q2w. Primary neutropenic fever prophylaxis with GCSFs x 3 days 2. CONCURRENT CHEMORADIOTHERAPY WITH 2 CYCLES OF CISPLATIN 100mg/m2 iv q3w

Drug: modified TPF; Other: Quality of life assessment (QoL)

Interventions

modified TPF DRUG

modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy

induction mTPF

Quality of life assessment (QoL) OTHER

Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H\&N-35

induction mTPF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN): oral cavity, oropharynx, larynx, hypopharynx, and unknown primary
• stage cT4 and/or cN2-N3, with no distant metastases (M0).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
• initial clinical staging evaluated in:
• CT scan or MRI of the neck and CT scan of the chest or
• FDG18 PET TC

You may not qualify if:

• patients with p16 positive oropharyngeal carcinoma cT0-T3 N2 M0 (stage II), unless extranodal tumor extension
• contraindications for cisplatin administration: renal insufficiency (eGFR \< 55ml/min), hearing loss, peripheral neuropathy
• dysphagia G\>2 with no percutaneous gastrostomy
• the presence of distant metastasis (M1)

Sponsors & Collaborators

• Hospital Universitario Doctor Peset: lead

Study Sites (3)

Hospital Marina Baixa

Villajoyosa, Alicante, 03570, Spain

Location

Hospital Comarcal Francesc De Borja

Gandia, Valencia, 46702, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Related Publications (17)

• Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

  PMID: 25651787 BACKGROUND

• Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.

  PMID: 23182993 BACKGROUND

• Department of Veterans Affairs Laryngeal Cancer Study Group; Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. doi: 10.1056/NEJM199106133242402.

  PMID: 2034244 BACKGROUND

• Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.

  PMID: 21684027 BACKGROUND

• Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

  PMID: 17960013 BACKGROUND

• Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

  PMID: 17960012 BACKGROUND

• Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.

  PMID: 23835714 BACKGROUND

• Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. doi: 10.1016/S1470-2045(13)70011-1. Epub 2013 Feb 13.

  PMID: 23414589 BACKGROUND

• Cohen EE, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, Brockstein BE, Agulnik MB, Mittal BB, Yunus F, Samant S, Raez LE, Mehra R, Kumar P, Ondrey F, Marchand P, Braegas B, Seiwert TY, Villaflor VM, Haraf DJ, Vokes EE. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. J Clin Oncol. 2014 Sep 1;32(25):2735-43. doi: 10.1200/JCO.2013.54.6309. Epub 2014 Jul 21.

  PMID: 25049329 BACKGROUND

• Burgy M, Leblanc J, Borel C. Any place left for induction chemotherapy for locally advanced head and neck squamous cell carcinoma? Anticancer Drugs. 2018 Apr;29(4):287-294. doi: 10.1097/CAD.0000000000000595.

  PMID: 29420335 BACKGROUND

• Hitt R, Grau JJ, Lopez-Pousa A, Berrocal A, Garcia-Giron C, Irigoyen A, Sastre J, Martinez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernandez JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. doi: 10.1093/annonc/mdt461. Epub 2013 Nov 19.

  PMID: 24256848 BACKGROUND

• Driessen CM, de Boer JP, Gelderblom H, Rasch CR, de Jong MA, Verbist BM, Melchers WJ, Tesselaar ME, van der Graaf WT, Kaanders JH, van Herpen CM. Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study. Eur J Cancer. 2016 Jan;52:77-84. doi: 10.1016/j.ejca.2015.09.024. Epub 2015 Dec 1.

  PMID: 26655558 BACKGROUND

• Kim R, Hahn S, Shin J, Ock CY, Kim M, Keam B, Kim TM, Kim DW, Heo DS. The Effect of Induction Chemotherapy Using Docetaxel, Cisplatin, and Fluorouracil on Survival in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis. Cancer Res Treat. 2016 Jul;48(3):907-16. doi: 10.4143/crt.2015.359. Epub 2015 Nov 17.

  PMID: 26582394 BACKGROUND

• Lau A, Li KY, Yang WF, Su YX. Induction chemotherapy for squamous cell carcinomas of the oral cavity: A cumulative meta-analysis. Oral Oncol. 2016 Oct;61:104-14. doi: 10.1016/j.oraloncology.2016.08.022. Epub 2016 Sep 7.

  PMID: 27688112 BACKGROUND

• Jerzak KJ, Delos Santos K, Saluja R, Lien K, Lee J, Chan KKW. A network meta-analysis of the sequencing and types of systemic therapies with definitive radiotherapy in locally advanced squamous cell carcinoma of the head and neck (LASCCHN)☆. Oral Oncol. 2017 Aug;71:1-10. doi: 10.1016/j.oraloncology.2017.05.011. Epub 2017 Jun 3.

  PMID: 28688674 BACKGROUND

• Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codeca C, Nole F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. doi: 10.1093/annonc/mdx299.

  PMID: 28911070 BACKGROUND

• Fayette J, Fontaine-Delaruelle C, Ambrun A, Daveau C, Poupart M, Ramade A, Zrounba P, Neidhardt EM, Peron J, Diallo A, Ceruse P. Neoadjuvant modified TPF (docetaxel, cisplatin, fluorouracil) for patients unfit to standard TPF in locally advanced head and neck squamous cell carcinoma: a study of 48 patients. Oncotarget. 2016 Jun 14;7(24):37297-37304. doi: 10.18632/oncotarget.8934.

  PMID: 27119503 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: May 1, 2019
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

ES (3)