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

University of Chinese Academy Sciences

Status and phase: Enrolling; Phase 2

Conditions: Nasopharyngeal Cancer; Neoplasm Metastasis

Treatments: Radiation: radical radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03129412

NPC-Oligo-M

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Arm 1

Experimental group

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.

Treatment:

Radiation: radical radiotherapy