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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypopharyngeal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induction chemotherapy and concurret chemoradiotherapy 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.

Group Type EXPERIMENTAL

Induction CT+ CRT group

Intervention Type DRUG

Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy

Concurrent chemoradiotherapy group

Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy

Group Type ACTIVE_COMPARATOR

Concurrent CRT group

Intervention Type RADIATION

cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy

Interventions

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Induction CT+ CRT group

Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy

Intervention Type DRUG

Concurrent CRT group

cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No