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

NCT03129412 | Unknown Phase 2

• 1 other identifier: NPC-Oligo-M
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Cancer; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progress free survival

  From date of diagnosis until the date of first documented progression, assessed up to 36 months

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Radiation: radical radiotherapy

Interventions

radical radiotherapy RADIATION

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

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shuang Huang, Dr

CONTACT

+8618258111085; huangshuang@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 26, 2017
• Study Start: April 14, 2017
• Primary Completion: April 23, 2023
• Study Completion: April 23, 2025
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)