SBRT for Extra-cranial Oligorecurrent Tumor

Recurrent Cancer Clinical Trial

Official title:

Stereotactic Body Radiotherapy for Extra-cranial Oligorecurrent Tumor: Randomized Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02410187
• Other study ID #: K-1503-001-002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 20, 2015
• Last updated: March 2, 2016
• Start date: March 2016
• Est. completion date: March 2020

Study information

• Verified date: March 2016
• Source: Korea Cancer Center Hospital
• Contact: Mi-Sook Kim, M.D. Ph.D.
• Phone: +82-2-970-1264
• Email: mskim[@]kirams.re.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Clinical experience has shown that metastasis can often be limited in number and location, and thus amenable to local treatment. The term oligometastasis describes an intermediate state of cancer spread between localized disease and widespread metastasis. The implication of such an intermediate state is that the disease can be cured by using metastasis-directed therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical resection was often indicated, as abundant evidence suggested it could improve progression-free or overall survival. Recently, several studies have reported promising outcomes of >80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver, non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have limitations of a retrospective nature and small sample sizes.Because allmost studies are based on single-arm studies without appropriate controls, the level of evidence to support SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for oligometastatic disease.

This study is designed as a randomized phase II study. Patients will be randomized between current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age <18 years old

• ECOG score: 0-2

• number of distant metastases: 1-5

• all cancers (except lymphoma, myeloma, and germ cell tumor)

• status of primary lesion: cured

• pathologically confirmed cancer

• life expectancy: over 6 months

Exclusion Criteria:

• recurrent lesion which had been treated by radiotherapy

• complete response after systemic therapy

• patients who cannot be treated with SBRT due to any reason.

• pregnancy or breast-feeding

• malignant pleural effusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrence
• Recurrent Cancer

Intervention

Radiation:
• SBRT
10 Gy x 3 - 20 Gy x 3 (BED 60Gy-180 Gy) or 8 Gy x 4 - 17 Gy x 4 (BED 58-184 Gy)

Drug:
• systemic therapy (chemotherapy, hormon therapy, target therapy etc)
Physicians can choose all the options available chemotherapy, hormon therapy, target therapy etc. Use of chemotherapy schemes containing potent enhancers of radiation damage (e.g. gemcitabine,adriamycin) are discouraged within the first month after SBRT.

Radiation:
• palliative RT
fraction size of RT = < 3 Gy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea Cancer Center Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression free survival rate		2 years	No
Secondary	overall survival rate		2 years	No
Secondary	local control rate		2 years	No
Secondary	Number of participants with radiation induced acute or late toxicity	Acute and late toxicities would be evaluated using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 and the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) radiation morbidity criteria, respectively.	2 years	Yes