Trial Title:
Radiotherapy Combined With Endostatin and Capecitabine for NPC
NCT ID:
NCT05514275
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Capecitabine
Endostatins
Conditions: Keywords:
Nasopharyngeal Carcinoma
Radiotherapy
Endostatin
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Radiotherapy Combined With Endostatin and Capecitabine
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Endostatin and Capecitabine
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)
Arm group label:
Endostatin and Capecitabine
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).
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Jin, MD
Phone:
+86-571-88128202
Email:
jinting@zjcc.org.cn
Facility:
Name:
the First Hospital of Jiaxing
Address:
City:
Jiaxing
Zip:
314000
Country:
China
Status:
Recruiting
Contact:
Last name:
Binbin Song
Facility:
Name:
Jinhua Central Hospital
Address:
City:
Jinhua
Zip:
321000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shubo Ding
Facility:
Name:
The Central Hospital of Lishui City
Address:
City:
Lishui
Zip:
323000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhifeng Tian, MD
Facility:
Name:
Ningbo First Hospital
Address:
City:
Ningbo
Zip:
315000
Country:
China
Status:
Recruiting
Contact:
Last name:
Pengrong Lou
Facility:
Name:
Ningbo Medical Center Lihuili Eastern Hospital
Address:
City:
Ningbo
Zip:
315000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Lu
Facility:
Name:
People's Hospital of Quzhou
Address:
City:
Quzhou
Zip:
324000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Peng
Start date:
August 1, 2022
Completion date:
August 1, 2028
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05514275
