2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

NCT06492460 | Recruiting Phase 3 DMC

• 1 other identifier: SL-B2024-323-02
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 5

Brief Summary

The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Concurrent chemoradiotherapy; Cisplatin; postoperative head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Failure-free survival (FFS)

  calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (4)

• Overall survival (OS)

  3 years

• Distant metastasis-free survival(DMFS)

  3 years

• locoregional recurrence-free survival (LRRFS)

  3 years

• Quality of life (QoL)

  3 years

Study Arms (2)

2 courses of cisplatin chemoradiotherapy arm

EXPERIMENTAL

Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22).

Drug: Drug：Cisplatin

3 courses of cisplatin chemoradiotherapy arm

EXPERIMENTAL

Patients will receive intensity modulated radiotherapy (total dose: \> 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, once every 3 weeks, 3 times in total, days 1, 22, and 43).

Drug: Drug：Cisplatin

Interventions

Drug：Cisplatin DRUG

Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy

Also known as: CDDP Drug

2 courses of cisplatin chemoradiotherapy arm; 3 courses of cisplatin chemoradiotherapy arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. The pathological type is head and neck squamous cell carcinoma
• Stages III and IV
• B. Radical surgery has been performed with high risk factors (one of below)
• extracapsular invasion of cervical metastatic lymph nodes
• positive incisional margin or inadequate incisional margin safety distance
• C. No evidence of distant metastasis (M0).
• D. Functional status: Karnofsky scale (KPS) \> 70.
• E. Normal bone marrow function:
• white blood cell count \> 4×109/L
• hemoglobin \> 120g/L in males, 110g/L in females
• platelet count \> 100×109/L
• G. Normal liver function:
• alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN)
• alkaline phosphatase (ALP) \< 2.5×ULN
• bilirubin \< ULN.

You may not qualify if:

• A. Age \>70 years or \<18 years.
• B. Treatment is palliative.
• C. Previous chemotherapy (except induction chemotherapy prior to surgery).
• D. Previous radiation therapy.
• E. Women who are pregnant or breastfeeding
• F. Previous history of malignant tumor.
• G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
• unstable heart disease that requires treatment
• kidney disease
• chronic hepatitis
• poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
• mental illness.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Hunan Cancer Hospital: collaborator
• Guilin Medical University, China: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Related Publications (21)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Wu C, Li M, Meng H, Liu Y, Niu W, Zhou Y, Zhao R, Duan Y, Zeng Z, Li X, Li G, Xiong W, Zhou M. Analysis of status and countermeasures of cancer incidence and mortality in China. Sci China Life Sci. 2019 May;62(5):640-647. doi: 10.1007/s11427-018-9461-5. Epub 2019 Mar 12.

  PMID: 30900169 BACKGROUND

• Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

  PMID: 15128894 BACKGROUND

• Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

  PMID: 15128893 BACKGROUND

• Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.

  PMID: 16161069 BACKGROUND

• Cooper JS, Zhang Q, Pajak TF, Forastiere AA, Jacobs J, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Lustig R, Ensley JF, Thorstad W, Schultz CJ, Yom SS, Ang KK. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1198-205. doi: 10.1016/j.ijrobp.2012.05.008. Epub 2012 Jun 30.

  PMID: 22749632 BACKGROUND

• Hartford AC, Palisca MG, Eichler TJ, Beyer DC, Devineni VR, Ibbott GS, Kavanagh B, Kent JS, Rosenthal SA, Schultz CJ, Tripuraneni P, Gaspar LE; American Society for Therapeutic Radiology and Oncology; American College of Radiology. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) Practice Guidelines for Intensity-Modulated Radiation Therapy (IMRT). Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):9-14. doi: 10.1016/j.ijrobp.2008.04.049. No abstract available.

  PMID: 19100920 BACKGROUND

• Lee NY, de Arruda FF, Puri DR, Wolden SL, Narayana A, Mechalakos J, Venkatraman ES, Kraus D, Shaha A, Shah JP, Pfister DG, Zelefsky MJ. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):966-74. doi: 10.1016/j.ijrobp.2006.06.040.

  PMID: 17145527 BACKGROUND

• Dogan N, King S, Emami B, Mohideen N, Mirkovic N, Leybovich LB, Sethi A. Assessment of different IMRT boost delivery methods on target coverage and normal-tissue sparing. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1480-91. doi: 10.1016/s0360-3016(03)01569-4.

  PMID: 14630288 BACKGROUND

• Lee NY, O'Meara W, Chan K, Della-Bianca C, Mechalakos JG, Zhung J, Wolden SL, Narayana A, Kraus D, Shah JP, Pfister DG. Concurrent chemotherapy and intensity-modulated radiotherapy for locoregionally advanced laryngeal and hypopharyngeal cancers. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):459-68. doi: 10.1016/j.ijrobp.2007.03.013. Epub 2007 May 9.

  PMID: 17493769 BACKGROUND

• Wu Q, Mohan R, Morris M, Lauve A, Schmidt-Ullrich R. Simultaneous integrated boost intensity-modulated radiotherapy for locally advanced head-and-neck squamous cell carcinomas. I: dosimetric results. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):573-85. doi: 10.1016/s0360-3016(02)04617-5.

  PMID: 12738335 BACKGROUND

• Adelstein DJ, Moon J, Hanna E, Giri PG, Mills GM, Wolf GT, Urba SG. Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216). Head Neck. 2010 Feb;32(2):221-8. doi: 10.1002/hed.21179.

  PMID: 19557750 BACKGROUND

• Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. doi: 10.1200/JCO.2012.42.3988. Epub 2013 Jan 22.

  PMID: 23341517 BACKGROUND

• Rades D, Kronemann S, Meyners T, Bohlen G, Tribius S, Kazic N, Schroeder U, Hakim SG, Schild SE, Dunst J. Comparison of four cisplatin-based radiochemotherapy regimens for nonmetastatic stage III/IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1037-44. doi: 10.1016/j.ijrobp.2010.03.033. Epub 2010 Jul 16.

  PMID: 20638185 BACKGROUND

• Lu HJ, Yang CC, Wang LW, Chu PY, Tai SK, Chen MH, Yang MH, Chang PM. Modified weekly cisplatin-based chemotherapy is acceptable in postoperative concurrent chemoradiotherapy for locally advanced head and neck cancer. Biomed Res Int. 2015;2015:307576. doi: 10.1155/2015/307576. Epub 2015 Feb 22.

  PMID: 25793192 BACKGROUND

• Geiger JL, Lazim AF, Walsh FJ, Foote RL, Moore EJ, Okuno SH, Olsen KD, Kasperbauer JL, Price DL, Garces YI, Ma DJ, Neben-Wittich MA, Molina JR, Garcia JJ, Price KA. Adjuvant chemoradiation therapy with high-dose versus weekly cisplatin for resected, locally-advanced HPV/p16-positive and negative head and neck squamous cell carcinoma. Oral Oncol. 2014 Apr;50(4):311-8. doi: 10.1016/j.oraloncology.2014.01.001. Epub 2014 Jan 24.

  PMID: 24467937 BACKGROUND

• Yau TK, Lee AW, Wong DH, Yeung RM, Chan EW, Ng WT, Tong M, Soong IS. Induction chemotherapy with cisplatin and gemcitabine followed by accelerated radiotherapy and concurrent cisplatin in patients with stage IV(A-B) nasopharyngeal carcinoma. Head Neck. 2006 Oct;28(10):880-7. doi: 10.1002/hed.20421.

  PMID: 16721741 BACKGROUND

• Marks LB, Yorke ED, Jackson A, Ten Haken RK, Constine LS, Eisbruch A, Bentzen SM, Nam J, Deasy JO. Use of normal tissue complication probability models in the clinic. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S10-9. doi: 10.1016/j.ijrobp.2009.07.1754.

  PMID: 20171502 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.

  PMID: 7713792 BACKGROUND

• Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.

  PMID: 12357184 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lei Chen, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Chen, M.D

CONTACT

+862013570051477; chenlei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 20, 2029
• Study Completion (Estimated): July 17, 2033
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)