Hypopharyngeal Cancer
Conditions
Keywords
Hypopharyngeal carcinoma, Locally advanced, Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Prognosis
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.
Interventions
DRUGInduction 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
RADIATIONConcurrent CRT group
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | 5 year | — |
| distant-metastasis free survival | 5 year | — |
| larynx-preservation rate | 5 year | — |
| treatment related toxicities | 2 year | hematology and surgery related complications |
Countries
China
Contacts
Primary ContactJunlin Yi, Professor
Outcome results
None listed