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Radiotherapy Combined With Endostatin and Capecitabine for NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostatin and Capecitabine
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting
  • the First Hospital of JiaxingRecruiting
  • Jinhua Central HospitalRecruiting
  • The Central Hospital of Lishui CityRecruiting
  • Ningbo First HospitalRecruiting
  • Ningbo Medical Center Lihuili Eastern HospitalRecruiting
  • People's Hospital of QuzhouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostatin and Capecitabine

Arm Description

Patients received radiotherapy Combined With Endostatin and Capecitabine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall survival (OS)
calculated from date of randomisation to death
distant metastasis-free survival (DMFS)
calculated from date of randomisation to the first distant failure
Local-regional free survival (LRFS)
calculated from date of randomisation to the first Local-regional failure
adverse events (AEs) and severe adverse events (SAE)
graded according to NCI CTCAE v5.0
quality of life (QoL)
the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0

Full Information

First Posted
August 21, 2022
Last Updated
August 21, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05514275
Brief Title
Radiotherapy Combined With Endostatin and Capecitabine for NPC
Official Title
Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Radiotherapy Combined With Endostatin and Capecitabine
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endostatin and Capecitabine
Arm Type
Experimental
Arm Description
Patients received radiotherapy Combined With Endostatin and Capecitabine
Intervention Type
Drug
Intervention Name(s)
Endostatin and Capecitabine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Recurrence free survival (RFS)
Description
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Description
calculated from date of randomisation to death
Time Frame
5 years
Title
distant metastasis-free survival (DMFS)
Description
calculated from date of randomisation to the first distant failure
Time Frame
3 years
Title
Local-regional free survival (LRFS)
Description
calculated from date of randomisation to the first Local-regional failure
Time Frame
3 years
Title
adverse events (AEs) and severe adverse events (SAE)
Description
graded according to NCI CTCAE v5.0
Time Frame
5 years
Title
quality of life (QoL)
Description
the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Jin, MD
Phone
+86-571-88128202
Email
jinting@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Jin, MD
Organizational Affiliation
Department of Radiation Oncology, Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Jin, MD
Phone
+86-571-88128202
Email
jinting@zjcc.org.cn
Facility Name
the First Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Song
Facility Name
Jinhua Central Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shubo Ding
Facility Name
The Central Hospital of Lishui City
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifeng Tian, MD
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengrong Lou
Facility Name
Ningbo Medical Center Lihuili Eastern Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Lu
Facility Name
People's Hospital of Quzhou
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Peng

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Radiotherapy Combined With Endostatin and Capecitabine for NPC

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