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

N

National Institutes of Health Clinical Center (CC)

Status and phase

Terminated
Phase 2

Conditions

Metastatic Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Melanoma (Skin)
Kidney Cancer
Ovarian Cancer

Treatments

Other: questionnaire administration
Radiation: hypofractionated radiation therapy
Radiation: tomotherapy
Radiation: image-guided radiation therapy
Radiation: 3-dimensional conformal radiation therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00550654
NCI-07-C-0230
070230

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

Radiation Therapy in Metastatic Cancer
Experimental group
Description:
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Treatment:
Radiation: 3-dimensional conformal radiation therapy
Radiation: image-guided radiation therapy
Radiation: tomotherapy
Radiation: hypofractionated radiation therapy
Other: questionnaire administration

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems