Radiotherapy Combined With Endostatin and Capecitabine for NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514275
• Other study ID #: RCECNPC
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: August 1, 2028

Study information

• Verified date: August 2022
• Source: Zhejiang Cancer Hospital
• Contact: Ting Jin, MD
• Phone: +86-571-88128202
• Email: jinting[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.

Description:

This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).

No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count =4000/µL, hemoglobin =90g/L and platelet count =100000/µL.

Normal liver function test: Alanine Aminotransferase (ALT)?Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) =2.5×ULN, and bilirubin =ULN.

Adequate renal function: creatinine clearance =60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.

unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 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.

satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Endostatin and Capecitabine
Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	the First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Jinhua Central Hospital	Jinhua	Zhejiang
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Medical Center Lihuili Eastern Hospital	Ningbo	Zhejiang
China	People's Hospital of Quzhou	Quzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival (RFS)	calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first	3 years
Secondary	overall survival (OS)	calculated from date of randomisation to death	5 years
Secondary	distant metastasis-free survival (DMFS)	calculated from date of randomisation to the first distant failure	3 years
Secondary	Local-regional free survival (LRFS)	calculated from date of randomisation to the first Local-regional failure	3 years
Secondary	adverse events (AEs) and severe adverse events (SAE)	graded according to NCI CTCAE v5.0	5 years
Secondary	quality of life (QoL)	the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0	3 years