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

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.