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

NCT ID: NCT02958111

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2023-12-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant capecitabine

Adjuvant chemotherapy with single-agent capecitabine

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

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

Observation

Clinical follow-up and surveillance only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Capecitabine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role: collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Cancer Hospital of Guizhou Province

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Jilin Provincial Tumor Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Cancer Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma, MD

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

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Other Identifiers

2016-FXY-075

Identifier Type: -

Identifier Source: org_study_id