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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Adjuvant chemotherapy, Capecitabine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-65
Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
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
Within 12-16weeks after completion of the recommended curative radiotherapy treatment
No clinical evidence of persistent loco-regional disease or distant metastases after radiotherapy
Complete the recommended concurrent chemotherapy ± induction chemotherapy
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)
Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

Patients who could not tolerate or allergic to capecitabine.
Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
Patients who received surgery treatment, biotherapy or immunotherapy during or before radiotherapy.
Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy.
History of previous radiotherapy before the curative radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes before the curative radiotherapy
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.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant capecitabine

Observation

Arm Description

Adjuvant chemotherapy with single-agent capecitabine

Clinical follow-up and surveillance only

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Distant failure-free survival

Locoregional failure-free survival

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30

Full Information

NCT ID

NCT02958111

First Posted

October 26, 2016

Last Updated

June 11, 2019

Sponsor

Sun Yat-sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02958111

Brief Title

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

Acronym

CAN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, Adjuvant chemotherapy, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

406 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant capecitabine

Arm Type

Experimental

Arm Description

Adjuvant chemotherapy with single-agent capecitabine

Arm Title

Observation

Arm Type

No Intervention

Arm Description

Clinical follow-up and surveillance only

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Patients will receive capecitabine (650 mg/m2 bid, p.o.，d1-21，q3wks; continued until disease progression, unacceptable toxicity, or over 1 year).

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

3 years

Title

Distant failure-free survival

Time Frame

3 years

Title

Locoregional failure-free survival

Time Frame

3 years

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

1 year

Title

Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-65 Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1 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 Within 12-16weeks after completion of the recommended curative radiotherapy treatment No clinical evidence of persistent loco-regional disease or distant metastases after radiotherapy Complete the recommended concurrent chemotherapy ± induction chemotherapy 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) Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: Patients who could not tolerate or allergic to capecitabine. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). Patients who received surgery treatment, biotherapy or immunotherapy during or before radiotherapy. Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy. History of previous radiotherapy before the curative radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes before the curative radiotherapy 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.

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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