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

Phase 2
18 Years
Not Enrolling
Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- 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.


- 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

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

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

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

Outcome Measure:

6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Deborah E. Citrin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Radiation Oncology Branch; ROB


United States: Federal Government

Study ID:




Start Date:

October 2007

Completion Date:

May 2010

Related Keywords:

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



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182