New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Phase 2

• Conditions: Hypopharyngeal Cancer
• Interventions: Drug: Induction CT+ CRT group; Radiation: Concurrent CRT group

• Registration Number: NCT03558035
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.

Detailed Description

Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(\>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29
• Primary Completion: 2021-02
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Histologically proven squamous cell carcinoma of hypopharynx
• Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
• Karnofsky Performance Status>=70
• Have measurable lesions on CT/MRI
• Treatment for the first time
• Expected lifetime > 6 months
• Normal blood test, hepatic and renal functions
• Normal hearing
• Can understand and sign the consent
• Have follow up condition

Exclusion Criteria

• Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
• Previously treatment for cancer
• Pregnant or breeding woman, female without contraception
• Enrolling in other drug trials
• Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
• Without follow up
• Receive target therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction chemotherapy and concurret chemoradiotherapy group	Induction CT+ CRT group	Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo.
Concurrent chemoradiotherapy group	Concurrent CRT group	Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy

Primary Outcome Measures

Name	Time	Method
overall survival	5 year

Secondary Outcome Measures

Name	Time	Method
distant-metastasis free survival	5 year
disease free survival	5 year
larynx-preservation rate	5 year
treatment related toxicities	2 year	hematology and surgery related complications

Trial Locations

Locations (1)

Cancer hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China