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

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ClinicalTrials.gov Identifier: NCT03558035
Recruitment Status : Unknown
Verified January 2021 by Jun-Lin Yi, MD, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 15, 2018
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Jun-Lin Yi, MD, Chinese Academy of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypopharyngeal Cancer Drug: Induction CT+ CRT group Radiation: Concurrent CRT group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Study Start Date : September 2014
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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
Active Comparator: Concurrent chemoradiotherapy group
Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
 Radiation: Concurrent CRT group
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 5 year ]
  2. distant-metastasis free survival [ Time Frame: 5 year ]
  3. larynx-preservation rate [ Time Frame: 5 year ]
  4. treatment related toxicities [ Time Frame: 2 year ]
    hematology and surgery related complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558035


Contacts
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Contact: Junlin Yi, Professor 0086013661217998 yijunlin1969@163.com

Locations
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China
Cancer hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Junlin YI, MD    861087788504    junlinyi@sohu.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Junlin Yi, Professor CAMS
More Information
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Publications:

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Responsible Party: Jun-Lin Yi, MD, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03558035    
Other Study ID Numbers: LC2014L12
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun-Lin Yi, MD, Chinese Academy of Medical Sciences:
Hypopharyngeal carcinoma
Locally advanced
Multi-disciplinary treatment
Functional Magnetic Resonance Imaging
Prognosis
Additional relevant MeSH terms:
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Carcinoma
Hypopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases