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Squamous Cell Carcinoma of Head and NeckPhase 3NCT06492460

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

A Phase 3 study testing Drug：Cisplatin in people with Squamous Cell Carcinoma of Head and Neck, run by Sun Yat-sen University at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Drug：Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
422 participants
Where
5 sitesChina
Study dates
20 Sep 2024to 17 Jul 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The pathological type is head and neck squamous cell carcinoma
  • Stages III and IV
  • 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
  • No evidence of distant metastasis (M0).
Show all 17Show fewer
  • Functional status: Karnofsky scale (KPS) > 70.
  • 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
  • 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.
  • Normal renal function: creatinine clearance > 60 ml/min.
  • Patients must be informed of the basic contents of this study and sign informed consent.

Who cannot join

  • Age >70 years or <18 years.
  • Treatment is palliative.
  • Previous chemotherapy (except induction chemotherapy prior to surgery).
  • Previous radiation therapy.
  • Women who are pregnant or breastfeeding
  • Previous history of malignant tumor.
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Chen, M.D contact

+862013570051477

chenlei@sysucc.org.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Bei Yang, M.D, +8673113507403512

    Not yet recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan

    Haijun Wu, M.D, +8673113975110101

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Lei Chen, M.D., +86-20-87343096, chenlei@sysucc.org.cn

    Recruiting

  • Affiliated Hospital of Guilin Medical College

    Guilin, Guangxi

    Wei Jiang, M.D, +8677313788561863

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Lirong Wu, M.D, +862513701588737

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized Controlled, Non-inferior Phase 3 Clinical Trial of 2 Courses of Concurrent Cisplatin Chemoradiotherapy Versus 3 Courses After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

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.

Read the detailed description

The main objective of the trial was to evaluate whether the 3-year failure-free survival (FFS) rate in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. The secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1, 22 and 43).

Being tested
Drug：Cisplatin
Keywords
Concurrent chemoradiotherapy, Cisplatin, postoperative head and neck squamous cell carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug：CisplatinDrug

    Also called CDDP 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

Study groups in NCT06492460
Study groupRoleWhat they receive
2 courses of cisplatin chemoradiotherapy armExperimentalPatients 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).
Receives: Drug: Drug：Cisplatin
3 courses of cisplatin chemoradiotherapy armExperimentalPatients 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).
Receives: Drug: Drug：Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure-free survival (FFS)

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

    Measured: 3 years

Secondary outcomes (4)

  1. Overall survival (OS)

    calculated from enrolment to the date of death from any cause.

    Measured: 3 years

  2. Distant metastasis-free survival(DMFS)

    calculated from enrolment to the date of first distant metastasis.

    Measured: 3 years

  3. locoregional recurrence-free survival (LRRFS)

    calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence.

    Measured: 3 years

  4. Quality of life (QoL)

    The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start20 Sep 2024
  3. Primary completion20 Sep 2029 (estimated)
  4. Study completion17 Jul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
422 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492460
Sponsor's protocol ID
SL-B2024-323-02
Status last verified
Aug 2025
First submitted
2 Jul 2024
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33538338

  • 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.

    PubMed 30900169

  • 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.

    PubMed 15128894

  • 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.

    PubMed 15128893

  • 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.

    PubMed 16161069

  • 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.

    PubMed 22749632

  • 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.

    PubMed 19100920

  • 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.

    PubMed 17145527

  • 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.

    PubMed 14630288

  • 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.

    PubMed 17493769

  • 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.

    PubMed 12738335

  • 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.

    PubMed 19557750

  • 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.

    PubMed 23341517

  • 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.

    PubMed 20638185

  • 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.

    PubMed 25793192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug：Cisplatin in people with Squamous Cell Carcinoma of Head and Neck, run by Sun Yat-sen University at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Chen, M.D (+862013570051477, chenlei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival (FFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492460, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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