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

Primary Purpose

Hypopharyngeal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Induction CT+ CRT group
Concurrent CRT group
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypopharyngeal Cancer focused on measuring Hypopharyngeal carcinoma, Locally advanced, Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Prognosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cancer hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction chemotherapy and concurret chemoradiotherapy group

Concurrent chemoradiotherapy group

Arm 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.

Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease free survival
distant-metastasis free survival
larynx-preservation rate
treatment related toxicities
hematology and surgery related complications

Full Information

First Posted
June 5, 2018
Last Updated
January 28, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03558035
Brief Title
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Official Title
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Cancer
Keywords
Hypopharyngeal carcinoma, Locally advanced, Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction chemotherapy and concurret chemoradiotherapy group
Arm Type
Experimental
Arm 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.
Arm Title
Concurrent chemoradiotherapy group
Arm Type
Active Comparator
Arm Description
Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Induction CT+ CRT group
Intervention Description
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
Radiation
Intervention Name(s)
Concurrent CRT group
Intervention Description
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
5 year
Title
distant-metastasis free survival
Time Frame
5 year
Title
larynx-preservation rate
Time Frame
5 year
Title
treatment related toxicities
Description
hematology and surgery related complications
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junlin Yi, Professor
Phone
0086013661217998
Email
yijunlin1969@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junlin Yi, Professor
Organizational Affiliation
CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junlin YI, MD
Phone
861087788504
Email
junlinyi@sohu.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21684027
Citation
Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
Results Reference
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PubMed Identifier
23835714
Citation
Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
Results Reference
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PubMed Identifier
19318632
Citation
Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. doi: 10.1093/jnci/djp007. Epub 2009 Mar 24.
Results Reference
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New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

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