Clinical trial NCT02958111: Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Adjuvant chemotherapy
Capecitabine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: Wuhan Union Hospital, China
name: Peking University
name: Air Force Military Medical University, China
name: Second Affiliated Hospital of Soochow University
name: West China Hospital
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
name: First People's Hospital of Foshan
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Cancer Hospital of Guizhou Province
name: Xiangya Hospital of Central South University
name: First Affiliated Hospital of Zhejiang University
name: Jilin Provincial Tumor Hospital
name: Henan Cancer Hospital
name: Hunan Cancer Hospital
name: The First Affiliated Hospital of Xiamen University
name: Cancer Hospital of Guangxi Medical University
First posted: 2016-11-08
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Distant failure-free survival
timeFrame: 3 years
measure: Locoregional failure-free survival
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
measure: Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
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