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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age ≥ 18 and ≤ 75 years.

Male or female.

Karnofsky physical status (KPS): ≥ 80

Disqualifiers

Distant metastatic disease

Have a history of other cancers or coinstantaneous second primary tumor

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

Patients who have participated in other clinical trials within 1 month before the test.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Docetaxel

    Drug

    60 mg/m2 i.v. day 1

  • Cisplatin

    Drug

    60 mg/m2 i.v. day 1-3

  • Capecitabine

    Drug

    750 mg/m2 po bid day 1-14

  • Concomitant chemoradiotherapy

    Radiation

    Radiotherapy: using intensity-modulated radiation therapy (IMRT) Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0\~2.2 Gy per day, 5 days per week Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65\~70 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Prophylactic irradiation for sites of suspected subclinical spread: 50\~60 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks.

  • Surgery

    Procedure/Surgery

    Neck dissection and primary tumor resection

Treatment groups

111 Participants
are divided into 2 treatment groups
Group A: Induction chemotherapy groupExperimental treatment 5 interventions
Group B: Surgery groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival rate

The proportion of patients with disease progress or death due to any reasons.

Time frame
3 years

Secondary outcomes

1

Overall survival rate

The proportion of dead patients due to any reasons.

Time frame
3 years
2

Local control

The proportion of patients with local recurrence.

Time frame
3 years
3

Regional control

The proportion of patients with regional recurrence.

Time frame
3 years
4

Metastasis-free survival

The proportion of patients with distant metastasis.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Shandong Provincial Hospital

Collaborator

Harbin Medical University Third Affiliated Hospital

Collaborator