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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Cancer; Neoplasm Metastasis
• Interventions: Radiation: radical radiotherapy

• Registration Number: NCT03129412
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2017-04-12
• Study Start: 2017-04-14
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17
• Primary Completion: 2023-04-23
• Study Completion: 2025-04-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	radical radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	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	Events of death caused by any reasons

Secondary Outcome Measures

Name	Time	Method
Progress free survival	From date of diagnosis until the date of first documented progression, assessed up to 36 months	adverse event including death, recurrence and metastases.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China