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

NCT03078699 | Completed

• 1 other identifier: PSSBRT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymoma; Thymic Tumor

Keywords

Thymoma; Thymic tumor; Stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (2)

• PFS (progression-free time)

  measured from the start of SBRT until any area in recurrence or distant metastasis, assessed up to 1 years

• Tumor response rate

  the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years

Study Arms (1)

stereotactic body radiation therapy

EXPERIMENTAL

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

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).

Also known as: Gamma knife

stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (2)

• 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.

  PMID: 23352916 BACKGROUND

• 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.

  PMID: 26974367 BACKGROUND

MeSH Terms

Conditions

Thymoma; Thymus Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 13, 2017
• Study Start: January 1, 2005
• Primary Completion: January 1, 2014
• Study Completion: September 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)