Prospective Study of Stereotactic Body Radiation Therapy for Thymoma Inoma: Therapeutic Effect and Toxicity Assessment

March 7, 2017 updated by: Xueqin Yang, Third Military Medical University

Prospective Ⅱ Study of Stereotactic Body Radiation Therapy for Thymoma and Thymic Carcinoma: Therapeutic Effect and Toxicity Assessment

For patients with unresectable or recurrent disease, radiation is routinely administered, often in combination with systemic chemotherapy. However, because of wide range of radiation, more complications of conventional radiotherapy limit its treatment dose. The local recurrence rates of conventional radiotherapy are dissatisfied.Stereotactic body radiation therapy(SBRT) well solved the problem above. On the one hand, by improving the single dose, it not only shortens the total radiation treatment, but also increases the total dose of equivalent biological effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thymoma is mainly divided into two types, invasive and noninvasive type, and more than 60% of patients belong to noninvasive thymoma. When feasible, complete surgical resection is the primary treatment. There are quite a number of thymoma patients that has lost its surgical indications when diagnosed. Even after complete resection, the recurrence rate can be about 20%. For patients with unresectable or recurrent disease, radiation is routinely administered, often in combination with systemic chemotherapy. However, because of wide range of radiation, more complications of conventional radiotherapy limit its treatment dose. The local recurrence rates of conventional radiotherapy are up 16% to 45%. Moreover, it's not suitable for patients with severe heart and lung disease. Stereotactic body radiation therapy(SBRT) well solved the problem above. On the one hand, by improving the single dose, it not only shortens the total radiation treatment, but also increases the total dose of equivalent biological effects; On the other hand, SBRT, with more precise conformal radiation therapy, significantly reduces the damage to the surrounding normal tissues. Theoretically, SBRT can improve the local control, as well greatly reduces incidence of the radiation pneumonia, pericarditis, tracheitis, esophagitis and so on. However, few studies focused on the treatment of thymoma by SBRT, except two case reports Here we performed a prospective study on the treatment of thymoma by SBRT. The purpose of this prospective study was a preliminary evaluation of feasibility, efficacy and toxicity ofγ-SBRT in the treatment of thymoma.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital, Third Military Medical University

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria: Histologic or cytologic diagnosis of thymoma, Stage II-IV.

    • Males or females between 18 Years to 75 Years.
    • No prior SBRT, if the surgery or chemotherapy has been administered, the interval is at least above four weeks.
    • Performance status of 0, 1 on the ECOG criteria. Expected survival is above three months.
    • At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
    • Patients can have the brain / meningeal metastasis history, but the metastasis must be treated by operation or radiotherapy), and clinically stable for at least 2 months.
    • Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function.
    • Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
    • If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 2 months after trial. If male, use of an approved contraceptive method during the study and 2 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
    • No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.

  • Exclusion Criteria:

    • No pathological or cytological evidence of cancer.
    • Inability to comply with protocol or study procedures.
    • Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
    • Pregnant or breast-feeding.
    • Enrollment in other study within 30 days.
    • Brain metastasis with symptoms.
    • Hypokalemic and intestinal obstruction history.

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
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stereotactic body radiation therapy
Radiation: stereotactic body radiation therapy
A total radiation dose of 35-50 Gy was delivered to the 50% isodose line covering at least 95% of the PTV (3.5-5Gy/fraction), and a total radiation dose of 49-70 Gy was delivered to the 70% isodose line covering at least 95% of GTV (4.9-7 Gy/fraction).
Other Names:
  • Gamma knife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PFS (progression-free time)
Time Frame: measured from the start of SBRT until any area in recurrence or distant metastasis, assessed up to 1 years
measured from the start of SBRT until any area in recurrence or distant metastasis, assessed up to 1 years
Tumor response rate
Time Frame: the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years
the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years

Collaborators and Investigators

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

Sponsor

Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2005

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSSBRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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