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Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma

Primary Purpose

Stage II, III, Nasopharyngeal Squamous Cell Carcinoma, Induction Chemotheray

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
IMRT
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II, III

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pathology confirmed nasopharyngeal squamous cell carcinoma.
  • Aged 18 to 70 years old;
  • Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
  • KPS≥70;
  • Have measurable lesions on CT/MRI before treatment;
  • Treatment for the first time;
  • At least 6 months lifetime was expected;
  • Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
  • 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

Sites / Locations

  • Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction chemotherapy(IC)+IMRT

Concurrent chemoradiotherapy(CCRT)

Arm Description

Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm

cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy

Outcomes

Primary Outcome Measures

progress free survival

Secondary Outcome Measures

overall survival
local-regional control
complete response
efficacy will be measured by RECIST1.1

Full Information

First Posted
March 31, 2019
Last Updated
January 28, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03908372
Brief Title
Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
Official Title
A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2025 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Detailed Description
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed. The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II, III, Nasopharyngeal Squamous Cell Carcinoma, Induction Chemotheray, Concurrent Chemoradiotherapy, Reduce Treatment Intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction chemotherapy(IC)+IMRT
Arm Type
Experimental
Arm Description
Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
Arm Title
Concurrent chemoradiotherapy(CCRT)
Arm Type
Active Comparator
Arm Description
cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy
Intervention Type
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
intensity-modulated radiotherapy
Intervention Description
IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.
Primary Outcome Measure Information:
Title
progress free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Title
local-regional control
Time Frame
5 years
Title
complete response
Description
efficacy will be measured by RECIST1.1
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pathology confirmed nasopharyngeal squamous cell carcinoma. Aged 18 to 70 years old; Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm; KPS≥70; Have measurable lesions on CT/MRI before treatment; Treatment for the first time; At least 6 months lifetime was expected; Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junlin Yi, M.D
Phone
008601366121799
Email
junlinyi@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junlin Yi, professor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijin
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junlin yi, MD
Phone
0086013661217998
Email
yijunlin1969@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29496056
Citation
Xu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20.
Results Reference
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PubMed Identifier
29323141
Citation
Liu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z.
Results Reference
background
PubMed Identifier
28264724
Citation
Yao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6.
Results Reference
background
PubMed Identifier
28243333
Citation
Xu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017.
Results Reference
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Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma

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