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

Primary Purpose

Thymoma, Thymic Tumor

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

stereotactic body radiation therapy

About this trial

This is an interventional treatment trial for Thymoma focused on measuring Thymoma, Thymic tumor, Stereotactic body radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stereotactic body radiation therapy

Arm Description

Outcomes

Primary Outcome Measures

PFS (progression-free time)

Tumor response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT03078699

First Posted

February 24, 2017

Last Updated

March 7, 2017

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03078699

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 1, 2005 (Actual)

Primary Completion Date

January 1, 2014 (Actual)

Study Completion Date

September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thymoma, Thymic Tumor

Keywords

Thymoma, Thymic tumor, Stereotactic body radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stereotactic body radiation therapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation therapy

Other Intervention Name(s)

Gamma knife

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Daping Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23352916

Citation

Baschnagel AM, Mangona VS, Robertson JM, Welsh RJ, Kestin LL, Grills IS. Lung metastases treated with image-guided stereotactic body radiation therapy. Clin Oncol (R Coll Radiol). 2013 Apr;25(4):236-41. doi: 10.1016/j.clon.2012.12.005. Epub 2013 Jan 24.

Results Reference

background

PubMed Identifier

26974367

Citation

Lee CM, Lee JD, Hobson-Webb LD, Bedlack RS, Salama JK. Treatment of Thymoma-Associated Myasthenia Gravis With Stereotactic Body Radiotherapy: A Case Report. Ann Intern Med. 2016 Aug 16;165(4):300-1. doi: 10.7326/L15-0469. Epub 2016 Mar 15. No abstract available.

Results Reference

background

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

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