Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma (CAN)

June 11, 2019 updated by: Jun Ma, MD, Sun Yat-sen University

Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN)

This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, NPC patients (stage III-IV A, except T3-4 N0 and T3 N1) who finished the curative radiotherapy will be randomized to the observation group and capecitabine group (650 mg/m2 bid, p.o.，d1-21，q3wks; continued until disease progression, unacceptable toxicity, or over 1 year). The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • 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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-65
  2. Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
  3. Tumor staged as American Joint Committee on Cance (AJCC) III-IV A (except T3-4 N0, T3 N1), with newly histologically confirmed non-keratinizing NPC
  4. Within 12-16weeks after completion of the recommended curative radiotherapy treatment
  5. No clinical evidence of persistent loco-regional disease or distant metastases after radiotherapy
  6. Complete the recommended concurrent chemotherapy ± induction chemotherapy
  7. Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min)
  8. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  1. Patients who could not tolerate or allergic to capecitabine.
  2. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
  3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  5. Patients who received surgery treatment, biotherapy or immunotherapy during or before radiotherapy.
  6. Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy.
  7. History of previous radiotherapy before the curative radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  8. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes before the curative radiotherapy
  9. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adjuvant capecitabine
Adjuvant chemotherapy with single-agent capecitabine
Drug: Capecitabine
Patients will receive capecitabine (650 mg/m2 bid, p.o.，d1-21，q3wks; continued until disease progression, unacceptable toxicity, or over 1 year).
NO_INTERVENTION: Observation
Clinical follow-up and surveillance only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 1 year
1 year
Distant failure-free survival
Time Frame: 3 years
3 years
Locoregional failure-free survival
Time Frame: 3 years
3 years
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Peking University
Xiangya Hospital of Central South University
Henan Cancer Hospital
West China Hospital
Tongji Hospital
Hunan Cancer Hospital
Jilin Provincial Tumor Hospital
First Affiliated Hospital of Zhejiang University
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
Air Force Military Medical University, China
First People's Hospital of Foshan
Second Affiliated Hospital of Soochow University
The First Affiliated Hospital of Xiamen University
Cancer Hospital of Guangxi Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Cancer Hospital of Guizhou Province

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

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (ESTIMATE)

November 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-FXY-075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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