Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma

January 28, 2021 updated by: Jun-Lin Yi, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijin, China, 100021
        • Recruiting
        • Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction chemotherapy(IC)+IMRT
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
Drug: Docetaxel
Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
Other Names:
  • Taxotere
Drug: Cisplatin
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
Other Names:
  • DDP
Radiation: IMRT
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.
Other Names:
  • intensity-modulated radiotherapy
Active Comparator: Concurrent chemoradiotherapy(CCRT)
cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
Drug: Cisplatin
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
Other Names:
  • DDP
Radiation: IMRT
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.
Other Names:
  • intensity-modulated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progress free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
5 years
local-regional control
Time Frame: 5 years
5 years
complete response
Time Frame: 13 weeks
efficacy will be measured by RECIST1.1
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Junlin Yi, professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

March 31, 2019

First Submitted That Met QC Criteria

April 7, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC1950

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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