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Recruiting NCT06492460

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

Phase III Interventional Squamous Cell Carcinoma of Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug：Cisplatin.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of Head and Neck. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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).

Interventions

  • Drug Drug：Cisplatin
    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

Primary outcome measures

  • Failure-free survival (FFS) [Time frame: 3 years]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: 3 years]
  • Distant metastasis-free survival(DMFS) [Time frame: 3 years]
  • locoregional recurrence-free survival (LRRFS) [Time frame: 3 years]
  • Quality of life (QoL) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

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.

H. Normal renal function: creatinine clearance > 60 ml/min.

I. Patients must be informed of the basic contents of this study and sign informed consent.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 5 centers
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Affiliated Hospital of Guilin Medical College — Guilin
  • Hunan Cancer Hospital — Changsha
  • Xiangya Hospital, Central South University — Changsha
  • Jiangsu Cancer Hospital — Nanjing

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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 (I PMID 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.2006.06.0 PMID 17145527

Identifiers

NCT: NCT06492460 · SL-B2024-323-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗