Spleen Radiotherapy Decreases Severe CIT in Advanced NSCLC (SPLEENIR)

July 27, 2022 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing

Spleen Radiotherapy Decreases Severe Chemotherapy Induced Thrombocytopenia (CIT) for the Multi-center Randomized Controlled Study in Advanced NSCLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spleen radiation plus spleen radiotherapy
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.
Radiation: spleen radiotherapy
Radiation: spleen radiation In Experimental arm, combine spleen radiation with chemotherapy. In Chemotherapy alone arm, the subjects should also receive spleen radiation once there is a severe CIT (≧grade III) during chemotherapy after radomization.
Other Names:
  • IMRT
Other: chemotherapy
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.
Radiation: spleen radiotherapy
Radiation: spleen radiation In Experimental arm, combine spleen radiation with chemotherapy. In Chemotherapy alone arm, the subjects should also receive spleen radiation once there is a severe CIT (≧grade III) during chemotherapy after radomization.
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of severe CIT afer chemotherapy
Time Frame: 18 weeks after randomization
18 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery time after severe bone marrow suppression
Time Frame: 18 weeks after randomization
18 weeks after randomization
Progression free suvival (PFS)
Time Frame: 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
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
Objective response rate (ORR)
Time Frame: Time Frame: 18 weeks after randomization
Time Frame: 18 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XQonc-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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