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Kidney CancerPhase 2NCT00550654

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

A Phase 2 study testing questionnaire administration, 3-dimensional conformal radiation therapy and hypofractionated radiation therapy in people with Kidney Cancer and Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer, Melanoma (Skin), Metastatic Cancer
What is being tested?
questionnaire administration, 3-dimensional conformal radiation therapy and hypofractionated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Oct 2007to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
questionnaire administration, 3-dimensional conformal radiation therapy, hypofractionated radiation therapy, image-guided radiation therapy, tomotherapy
Keywords
unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, recurrent melanoma, recurrent osteosarcoma, recurrent renal cell cancer, recurrent uterine sarcoma, stage IV adult soft tissue sarcoma, stage IV melanoma, stage IV uterine sarcoma, ovarian sarcoma, chondrosarcoma, metastatic osteosarcoma, stage IV renal cell cancer, lung metastases, liver metastases, bone metastases
Medical subject headings
Kidney Neoplasms, Melanoma, Neoplasm Metastasis, Ovarian Neoplasms, Sarcoma, Osteosarcoma, Carcinoma, Renal Cell, Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire administrationOther

    Also called Brief Pain Inventory

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

  • 3-dimensional conformal radiation therapyRadiation

    Conformal radiation therapy improves the ability to spare normal tissues.

  • hypofractionated radiation therapyRadiation

    Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.

  • image-guided radiation therapyRadiation

    Image guided radiation therapy targets the specific site of disease.

  • tomotherapyRadiation

    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.

Study groups in NCT00550654
Study groupRoleWhat they receive
Radiation Therapy in Metastatic CancerExperimentalPatients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Receives: Other: questionnaire administration; Radiation: 3-dimensional conformal radiation therapy; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy; Radiation: tomotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: 9 months, 11 days

  2. Median Time to Local Progression

    Interval from initiation of treatment on protocol to symptomatic or radiographic progression.

    Measured: 6-12 months

  3. 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment

    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.

    Measured: 12 months

  4. Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis

    Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.

    Measured: One to three months of followup

  5. Pain at Sites of Metastases

    Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.

    Measured: One and three months of follow up

  6. Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy

    Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.

    Measured: Baseline and prior to termination of systemic therapy or protocol withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

Why it stopped: Study was terminated due to poor accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00550654
Sponsor's protocol ID
070230
Other IDs
NCI-07-C-0230
Status last verified
Nov 2016
First submitted
25 Oct 2007
Last updated
13 Jan 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing questionnaire administration, 3-dimensional conformal radiation therapy and hypofractionated radiation therapy in people with Kidney Cancer and Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00550654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.

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