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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Hypopharyngeal Cancer

Treatments: Drug: Induction CT+ CRT group; Radiation: Concurrent CRT group

Study type: Interventional

Funder types: Other

Identifiers

NCT03558035

LC2014L12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Induction chemotherapy and concurret chemoradiotherapy group

Experimental group

Description:

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.

Treatment:

Drug: Induction CT+ CRT group

Concurrent chemoradiotherapy group

Active Comparator group

Description:

Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy

Treatment:

Radiation: Concurrent CRT group