Clinical trial NCT02650700: Spleen Radiotherapy Decreases Severe CIT in Advanced NSCLC (SPLEENIR)
Official title: Spleen Radiotherapy Decreases Severe Chemotherapy Induced Thrombocytopenia (CIT) for the Multi-center Randomized Controlled Study in Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy in Non-Small Cell Lung Cancer
Keywords: spleen radiation
IMRT
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of severe CIT afer chemotherapy
timeFrame: 18 weeks after randomization
Secondary outcomes:
measure: Recovery time after severe bone marrow suppression
timeFrame: 18 weeks after randomization
measure: Progression free suvival (PFS)
timeFrame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
measure: Objective response rate (ORR)
timeFrame: Time Frame: 18 weeks after randomization
Other outcomes:
Locations:
Study officials:
References: