Clinical trial NCT01345539: Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation
Official title: Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Oligometastatic Disease
Keywords: Oligo mets
Radiosurgery
Stereotactic Body Radiotherapy (SBRT) (Stereotactic radiosurgery (SRS) plus stereotactic radiotherapy (SRT))
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Death from metastatic cancer is a common cause of death, accounting for 80-90% of cancer deaths. The classic thought process is that metastatic disease represents the continuum such that known metastatic disease is an inevitable harbinger for subsequent metastatic disease. However, it has been reported that a subset of patients with limited volume metastatic disease may have a better prognosis if given aggressive therapy. This group of patients has become known as "oligometastatic". These patients are potentially curable with stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) (collectively referred to as stereotactic body radiotherapy or SBRT) to the metastatic disease sites in combination with standard curative therapy to the primary site. Patients in this study receive SRS/SBRT to all sites of oligometastatic disease.

Eligibility criteria: Inclusion Criteria:

1. Pathologically (histologically or cytologically) proven diagnosis of solid malignancy within 8 weeks of registration
2. 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)
3. 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

1 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).

  5Primary disease site must be able to be treated with curative intent 6Zubrod Performance Status 0-1 7Age ≥ 18 8CBC/differential obtained within 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
* Platelets ≥ 100,000 cells/mm3;
* Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); 9Women of childbearing potential and male participants must practice adequate contraception 10Patient must provide study specific informed consent prior to study entry.

Exclusion Criteria:

1. Ineligible disease sites include the following

   * Lymphoma
   * Leukemia
   * Multiple myeloma
   * Primary CNS
   * Peritoneal carcinomatosis
   * Colon cancer with resectable liver-only lesions
2. 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)
3. 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.
4. 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.
5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
6. Severe, active co-morbidity, defined as follows:

   * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
   * Transmural myocardial infarction within the last 6 months;
   * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
   * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
   * Immuno-compromised patients.
7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
8. Oligometastatic disease sites not eligible based on concern for toxicity:

   * trachea involvement (direct invasion, tumors close to or abutting trachea are eligible)
   * heart (direct invasion or involvement, pericardial lymph nodes can be treated)
9. Patients unable to have an FDG-PET/CT scan, either through insurance coverage, patient decision or other reason are not eligible for this study.
10. Patients unable to have SRS through insurance coverage or ability to pay for SRS

Primary outcomes:
measure: Acceptable Toxicity of SRS/SBRT
timeFrame: Up to 3 Years (per patient)
measure: Presence of Multiple Metastatic Sites
timeFrame: Up to 3 years (per patient)
Secondary outcomes:
measure: The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
timeFrame: At pre-treatment
measure: The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
timeFrame: At post-treatment
measure: Local Control of Metastatic Disease
timeFrame: Up to 5 years (per patient)
measure: Local Control of Primary Disease
timeFrame: Up to 5 years
measure: Analysis of Patterns of Failure Post-SRS/SBRT
timeFrame: Up to 5 years (per patient)
measure: Two-year Overall Survival
timeFrame: At 2 years (cohort)
measure: Overall Survival (OS)
timeFrame: Up to 5 years (cohort)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: Steve J Burton, MD
role: PRINCIPAL_INVESTIGATOR
References: