Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

• ClinicalTrials.gov Identifier: NCT02143388
• Recruitment Status: Completed
• First Posted: May 21, 2014
• Last Update Posted: August 31, 2022
• Sponsor: Zhao Chong
• Collaborators: Jiangxi Provincial Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; National Cancer Centre, Singapore
• Information provided by (Responsible Party): Zhao Chong, Sun Yat-sen University

Tracking Information

• First Submitted Date: May 7, 2014
• First Posted Date: May 21, 2014
• Last Update Posted Date: August 31, 2022
• Actual Study Start Date: March 31, 2014
• Actual Primary Completion Date: July 27, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2021)

Failure free survival [ Time Frame: 3-year ]

Defined as the time from date of recruitment to documented relapse or death from any cause.

Original Primary Outcome Measures (submitted: May 18, 2014)

Progression free survival [ Time Frame: 18 months ]

Defined as the time in months from first dose of cisplatin until PD is observed or death occurs due to any cause.

Current Secondary Outcome Measures (submitted: May 18, 2014)

Acute Toxicity [ Time Frame: 18 months ]

To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 28, 2021)

• Locoregional relapse free survival [ Time Frame: 3-year ]
  Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
• Distance metastasis free survival [ Time Frame: 3-year ]
  Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.
• Overall survival rate [ Time Frame: 3-year ]
  Defined as the time from date of recruitment to death from any cause.
• Late Toxicity [ Time Frame: 3 years ]
  To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Original Other Pre-specified Outcome Measures (submitted: May 18, 2014)

• Three-year locoregional relapse free survival rate [ Time Frame: 3 years ]
• Three-year distance metastasis free survival rate [ Time Frame: 3 years ]
• Three-year overall survival rate [ Time Frame: 3 years ]
• Late Toxicity [ Time Frame: 3 years ]
  To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Descriptive Information

• Brief Title: Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
• Official Title: Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
• Brief Summary: This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Local Advanced High Risk Nasopharyngeal Carcinoma

Intervention

• Drug: IMRT combine with cisplatin concurrent chemotherapy
  Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.
• Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
  Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Study Arms

• Experimental: Concurrent chemoradiation + adjuvant chemotherapy
  IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
  Intervention: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
• Active Comparator: Concurrent chemoradiation
  IMRT combine with cisplatin concurrent chemotherapy
  Intervention: Drug: IMRT combine with cisplatin concurrent chemotherapy

• Publications *: Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2018): 180
• Original Estimated Enrollment (submitted: May 18, 2014): 258
• Actual Study Completion Date: August 5, 2022
• Actual Primary Completion Date: July 27, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
• Clinical stage III~IVb(UICC 7th)
• Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
• Range from 18～70 years old
• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
• ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
• OSerum creatinine < 1.5×ULN

Exclusion Criteria:

• Central nervous system metastases
• Suitable for local treatment
• Uncontrolled seizure disorder or other serious neurologic disease
• Clinically significant cardiac or respiratory disease
• Drug or alcohol addition
• Do not have full capacity for civil acts
• Severe complication, active infection
• Concurrent immunotherapy or hormone therapy for other diseases
• Pregnancy or lactation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02143388
• Other Study ID Numbers: CCRT-AC-LAHR-NPC
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Zhao Chong, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhao Chong
• Original Study Sponsor: Same as current

Collaborators

• Jiangxi Provincial Cancer Hospital
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• National Cancer Centre, Singapore

Investigators

• Principal Investigator: zhao chong, M.D; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: August 2022