SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma

NCT04351282 | Not Yet Recruiting

• 1 other identifier: NPC-SBRT
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.

Conditions

Nasopharyngeal Carcinoma; Metastasis; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of diagnosis until the date of death from any cause

  up to 3 years

Secondary Outcomes (4)

• Progress free survival

  up to 3 years

• Previous Metastatic Progression Free Survival

  up to 3 years

• New Metastatic Free Survival

  up to 3 years

• Adverse Event

  up to 3 years

Study Arms (1)

SBRT

EXPERIMENTAL

4-6 cycles of chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors were given. SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.

Radiation: SBRT

Interventions

SBRT RADIATION

SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.

SBRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm)
• age 18-70 years old
• Karnofsky scores ≥70
• Estimated life ≥ 6 months
• Adequate organ function including the following: Absolute neutrophil count (ANC) \>= 2.0 \* 109/l; Platelets count \>= 100 \* 109/l ;Hemoglobin \>= 90 g/dl; Creatinine clearance \>= 60 ml/min; For patients without liver metastasis, AST and ALT \<= 1.5 times institutional upper limit of normal (ULN), Total bilirubin \<= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT \<= 3 times institutional upper limit of normal (ULN), Total bilirubin \<= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume \>700 mL
• Signed written informed consent

You may not qualify if:

• Patients who achieve complete remission after comprehensive treatment
• Pathology confirmed as second primary tumor
• Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy
• Femoral bone metastasis
• With serious medical complications and contraindications of radiotherapy
• With uncontrollable malignant pleural effusion
• Positive pregnancy test for women of childbearing age or lactating women
• Uncontrolled or active infections, such as immunodeficiency or HIV infection
• Active mental disorder or other mental disorder that affects the patient's ability to sign informed consent and understanding.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 17, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

CN (1)