The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

Last updated: September 13, 2024
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Lung Cancer

Head And Neck Cancer

Treatment

Docetaxel

Cisplatin

Capecitabine

Clinical Study ID

NCT05494190
EENTHN0706
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to understand and willing to sign a written informed consent document.

  2. Age ≥ 18 and ≤ 75 years.

  3. Male or female.

  4. Karnofsky physical status (KPS): ≥ 80

  5. Hepatic function, renal function and normal blood test. Hepatic function: Alanineaminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal.Kidney function: Serum creatinine < upper limit of normal value and creatinineclearance rate > 60 ml/(min*1.73m2) (Cockcroft-Gault formula). Blood test:neutrophil (Neu) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (HGB) ≥ 90 g/L.

  6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.

  7. After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0stage according to American Joint Committee on Cancer (AJCC, eighth edition).

  8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotidvascular).

  9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).

  10. Radical treatment intent.

  11. Male patients with fertility and female patients with fertility and pregnancy riskmust agree to use contraceptive methods throughout the study period, and continueduntil at least 6 months after the last dose of cisplatin. Female patients who do nothave fertility (ie meet at least one of the following criteria): Have undergonehysterectomy and/or bilateral oophorectomy with archival records, medicallyconfirmed ovarian function decline; In postmenopausal state. It is defined as: Atleast 12 months of continuous menstruation without other pathological orphysiological reasons, and the status confirmed by serum follicle stimulatinghormone (FSH) levels is consistent with postmenopausal status.

  12. Good compliance.

Exclusion

Exclusion Criteria:

  1. Distant metastatic disease

  2. Have a history of other cancers or coinstantaneous second primary tumor

  3. Previous treatment for the primary tumor, including radiotherapy, surgery exceptbiopsy operation, chemotherapy, immunotherapy and biological targeted therapy.

  4. Patients who have participated in other clinical trials within 1 month before thetest.

  5. Patients estimated to have poor tolerance to induction chemotherapy.

  6. The investigator believes that it is inappropriate for individuals to participate inthe trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia,pulmonary fibrosis) or mental illness (including recent time [within the past year]or active suicidal ideation or behavior).

  7. Palliative treatment intent.

  8. Pregnant or lactating women.

Study Design

Total Participants: 111
Treatment Group(s): 5
Primary Treatment: Docetaxel
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
November 30, 2025

Study Description

Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.

Connect with a study center

  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing 100021
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Eye & ENT Hospital, Fudan University

    Shanghai, Shanghai 200031
    China

    Active - Recruiting

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