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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

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

NCT ID

NCT05514275

First Posted

August 21, 2022

Last Updated

August 21, 2022

Sponsor

Zhejiang Cancer Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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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