Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

NCT01345539 | Terminated Phase 2 Results DMC FDA Device

• 1 other identifier: HCC 10-027
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.

Conditions

Oligometastatic Disease

Keywords

Oligo mets; Radiosurgery; Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))

Outcome Measures

Primary Outcomes (2)

• Acceptable Toxicity of SRS/SBRT

  Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0

  Up to 3 Years (per patient)

• Presence of Multiple Metastatic Sites

  The presence of multiple metastatic disease sites (between 2 and 5 sites).

  Up to 3 years (per patient)

Secondary Outcomes (7)

• The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score

  At pre-treatment

• The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score

  At post-treatment

• Local Control of Metastatic Disease

  Up to 5 years (per patient)

• Local Control of Primary Disease

  Up to 5 years

• Analysis of Patterns of Failure Post-SRS/SBRT

  Up to 5 years (per patient)

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy

EXPERIMENTAL

Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease. Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.

Radiation: Stereotactic Radiosurgery (SRS); Drug: Chemotherapy

Interventions

Stereotactic Radiosurgery (SRS) RADIATION

Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.

Also known as: CyberKnife, Trilogy, True Beam

Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy

Chemotherapy DRUG

Chemotherapy choice of agents is at the discretion of the treating medical oncologist.

Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of solid malignancy within 8 weeks of registration
• Eligible disease sites include the following
• Breast
• Prostate
• GI (including colorectal, anal, esophagus, pancreas, gastric with the exception of colon cancer with resectable liver-only lesions)
• Head and neck
• Skin (melanoma and squamous cell carcinoma)
• Lung (both small cell and non-small cell)
• Sarcoma (both soft tissue and bone)
• Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
• Patients are stage IV (M1) with any combination of T and N with oligometastatic disease as defined by 5 or fewer total sites of metastatic disease involving 3 or fewer organ systems
• Examples of patients eligible for trial
• T3N2M1 NSCLC with 1 CNS metastatic lesion, 2 liver lesions, and 1 adrenal lesion.
• T4N1M1 colorectal cancer with 1 liver lesion, 4 bone lesions
• T3N0M1 gastric cancer with 1 supraclavicular lymph node, 2 liver lesions, and 2 CNS lesions 4Metastatic disease sites must be treatable with SRS (at discretion of treating physician).

You may not qualify if:

• Ineligible disease sites include the following
• Lymphoma
• Leukemia
• Multiple myeloma
• Primary CNS
• Peritoneal carcinomatosis
• Colon cancer with resectable liver-only lesions
• Examples of patients ineligible for trial
• T1N1M1 NSCLC with 1 CNS lesion, 1 bone lesion, 1 adrenal lesion and a cervical lymph node (4 sites of metastatic disease)
• T2N1M1 Gastric cancer with 6 liver lesions (more than 5 sites of metastatic disease)
• Other
• Lung cancer with pleural effusion (wet IIIB) are not eligible
• Recurrent cancers are not eligible
• Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis.
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable but cannot have any other primary cancer diagnosed or treated within the last 3 years other than cutaneous skin cancers. Patient may have previous chemotherapy as treatment of this previous malignancy as long as the chemotherapy has completed more than 3 years ago.

Sponsors & Collaborators

• Steven Burton: lead

Study Sites (1)

UPMC Hillman Cancer Center - Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Snyder Robinson syndrome

Interventions

Radiosurgery; Drug Therapy

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Barbara M. Stadterman, MPH, MSCR
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Steve J Burton, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: May 2, 2011
• Study Start: June 7, 2013
• Primary Completion: May 3, 2022
• Study Completion: October 20, 2022
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)