Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129412
• Other study ID #: NPC-Oligo-M
• Status: Recruiting
• Phase: Phase 2
• Start date: April 14, 2017
• Est. completion date: April 23, 2025

Study information

• Verified date: September 2020
• Source: Zhejiang Cancer Hospital
• Contact: Shuang Huang, Dr
• Phone: +8618258111085
• Email: huangshuang[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 23, 2025
• Est. primary completion date: April 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.

2. Clinical stages,T1-4N0-3M1,IVc(AJCC 2010).

3. The metastatic lesions =5 and metastatic organs =2

4. Karnofsky scores >70

5. 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).

6. Informed consent signed.

Exclusion Criteria:

1. Histologically conformed initial keratinizing carcinoma or others.

2. The metastatic lesions >5 or metastatic organs >2.

3. Any severe complications contraindicated chemotherapy or radiotherapy.

4. History of malignant tumors.

5. Pregnant or nursing women.

6. History of radiotherapy or chemotherpy in head and neck regions.

7. Patients refused the informed consent.

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• radical radiotherapy
radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	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	Overall survival	Events of death caused by any reasons	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	Progress free survival	adverse event including death, recurrence and metastases.	From date of diagnosis until the date of first documented progression, assessed up to 36 months