Back to resultsOligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions
Primary Purpose
Nasopharyngeal Cancer, Neoplasm Metastasis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
radical radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
- Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
- The metastatic lesions ≤5 and metastatic organs ≤2
- Karnofsky scores >70
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
- Informed consent signed.
Exclusion Criteria:
- Histologically conformed initial keratinizing carcinoma or others.
- The metastatic lesions >5 or metastatic organs >2.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- History of malignant tumors.
- Pregnant or nursing women.
- History of radiotherapy or chemotherpy in head and neck regions.
- Patients refused the informed consent.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy.
Outcomes
Primary Outcome Measures
Overall survival
Events of death caused by any reasons
Secondary Outcome Measures
Progress free survival
adverse event including death, recurrence and metastases.
Full Information
NCT ID
NCT03129412
First Posted
April 12, 2017
Last Updated
September 16, 2020
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03129412
Brief Title
Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions
Official Title
The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
April 23, 2023 (Anticipated)
Study Completion Date
April 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.
Detailed Description
The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer, Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
radical radiotherapy
Intervention Description
radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.
Primary Outcome Measure Information:
Title
Overall survival
Description
Events of death caused by any reasons
Time Frame
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary Outcome Measure Information:
Title
Progress free survival
Description
adverse event including death, recurrence and metastases.
Time Frame
From date of diagnosis until the date of first documented progression, assessed up to 36 months
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:
Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
The metastatic lesions ≤5 and metastatic organs ≤2
Karnofsky scores >70
Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
Informed consent signed.
Exclusion Criteria:
Histologically conformed initial keratinizing carcinoma or others.
The metastatic lesions >5 or metastatic organs >2.
Any severe complications contraindicated chemotherapy or radiotherapy.
History of malignant tumors.
Pregnant or nursing women.
History of radiotherapy or chemotherpy in head and neck regions.
Patients refused the informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Huang, Dr
Phone
+8618258111085
Email
huangshuang@zjcc.org.cn
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuan Huang
Phone
+8618258111085
Email
huangshuang@zjcc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions
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