Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00550654
• Other study ID #: 070230
• Secondary ID: NCI-07-C-0230
• Status: Terminated
• Phase: Phase 2
• First received: October 25, 2007
• Last updated: September 29, 2015
• Start date: October 2007
• Est. completion date: May 2010

Study information

• Verified date: September 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.

Description:

OBJECTIVES:

Primary

• To evaluate local control (defined as absence of local progression) at all treated sites of metastatic disease in patients with extracranial oligometastases treated with ablative doses of highly conformal radiotherapy delivered with helical tomotherapy.

• To evaluate local control at each treated site of metastatic disease in these patients.

Secondary

• To determine median time to local progression in patients treated with this regimen.

• To evaluate interfraction and intrafraction motion with megavoltage computed tomography (CT) imaging based on site of metastasis in these patients.

• To compare tumor growth during systemic therapy in tumors treated with targeted radiotherapy vs newly developed tumors that have not been treated with radiotherapy.

• To evaluate if treatment with hypofractionated highly conformal radiotherapy with helical tomotherapy can improve pain scores and decrease the need for analgesia in these patients.

OUTLINE: Patients are stratified according to histology (renal cell carcinoma vs melanoma vs sarcoma vs other histologies).

Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. Patients undergo megavoltage imaging before and after each fraction to verify the positioning of each target lesion.

Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after treatment.

After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Pathologically confirmed cancer

• No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging

• Measurable metastatic disease meeting the following criteria:

• Four or fewer sites of extracranial lesions < 5 cm in size

• If metastatic site(s) is within the lung, the following criteria must be met:

• No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi)

• Carbon monoxide diffusing capacity (DLCO) > 30% predicted and forced expiratory volume 1 (FEV1) > 1.2 L (in patients with more than one metastatic site in the lungs)

• If metastatic site(s) is within 2 cm of either kidney, creatinine level must be < 1.5 times upper limit of normal (ULN)

• If metastatic site(s) is within 2 cm of the liver, bilirubin level must be < 1.5 times ULN

• Patients with metastatic disease that meets any of the following criteria are excluded:

• Proposed site(s) of treatment has been previously treated with radiotherapy

• Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction)

• Disease that is untreated or previously treated and progressive in the brain

• Pathologic fracture or impending pathologic fracture at the metastatic site

• Metastatic site(s) of a disease histology that is known to be sensitive to low doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma)

• Patients in whom surgery is deemed an appropriate option as standard of care (e.g., isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) but who refuse surgical therapy are eligible

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy > 12 weeks as assessed by the consulting radiation oncologist

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of lupus erythematosus or scleroderma

• No known hypersensitivity to therapeutic radiotherapy

• No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck

• No unrelated systemic illness that, in the judgment of the investigator, would compromise the patient's ability to tolerate study therapy or would likely interfere with study procedures or results

• Able or likely to adhere to study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 2 weeks since prior and no concurrent chemotherapy

• Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed

• No change in systemic therapy for 6 weeks before or within 4 weeks after initiating study radiotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Ovarian Cancer
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• questionnaire administration
Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.

Radiation:
• 3-dimensional conformal radiation therapy
Conformal radiation therapy improves the ability to spare normal tissues.
• hypofractionated radiation therapy
Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
• image-guided radiation therapy
Image guided radiation therapy targets the specific site of disease.
• tomotherapy
Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease	Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.	6 months	No
Secondary	Number of Participants With Adverse Events	Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.	9 months, 11 days	Yes