Spleen Radiotherapy Decreases Severe CIT in Advanced NSCLC (SPLEENIR)

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Chemotherapy in Non-Small Cell Lung Cancer

Treatments: Radiation: spleen radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02650700

XQonc-002

Details and patient eligibility

About

Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy of cancer.

Although platelet transfusion is the gold standard to treat severe CIT, its clinical application is limited due to many disadvantages, such as short time for storage, not easy to save, the risk of infection and immunological diseases. What's more, other cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to explore a new therapeutic method to treat CIT.

Researches show that spleen resection could improve the count of PLT. In this clinical trial, we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC, simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time from bone marrow suppression and progression free survival, and the exploring index is the immulogical status.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable
2. ECOG whole body status (performancestatus,PS) level 0 or 1
3. The estimated survival time is more than 12 weeks, 18 ~75 years old
4. Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count > 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet > 50,000/ MCL; ③ Total bilirubin < 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) < 2.5 times of the normal upper limit; ⑤ Serum creatinine < 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
5. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
6. Understand and voluntarily sign written informed consent
7. The investigator judged that the patient had good compliance

Exclusion criteria

1. Patients with serious functional damage of important organs;
2. Patients diagnosed adequately with other malignant tumors;
3. Pregnant or lactating women;
4. Patients in an active period of acute or chronic infectious diseases;
5. Combined with the disease of connective tissue
6. Patients who are allergic to any drugs or people with allergies;
7. Patients who participate in other clinical trials concurrently;
8. Brain metastases without being controlled;
9. With immunologic thrombocytopenia；
10. Excluding thrombocytopenia caused by other reasons(Non chemotherapeutic agents, such as heparin, etc.);
11. The degree of tumor thrombus >2;
12. Patients who are considered not eligible for the trial after evaluation by investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

spleen radiation plus spleen radiotherapy

Experimental group

Description:

Chemotherapy plus spleen radiotherapy Chemotherapy plus spleen radiotherapy are performed, simultaneously, to the subjects with advanced lung cancer who experienced chemotherapy induced thrombocytopenia (≧grade II CIT). The intervention is spleen radiotherapy.

Treatment:

Radiation: spleen radiotherapy

chemotherapy

Other group

Description:

Chemotherapy is performed to the subjects with advanced lung cancer who experienced chemotherapy induced thrombocytopenia (≧grade II CIT). When severe CIT (≧grade III) occurs, the subjects should receive chemotherapy plus spleen radiotherapy. The intervention is spleen radiotherapy.

Treatment:

Radiation: spleen radiotherapy