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

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT00550654
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific	Other: questionnaire administration; Radiation: 3-dimensional conformal radiation therapy; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy; Radiation: tomotherapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Radiation Therapy in Metastatic Cancer Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.

Other: questionnaire administration; Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.; Other Names: Brief Pain Inventory ; Radiation: 3-dimensional conformal radiation therapy; Conformal radiation therapy improves the ability to spare normal tissues.; Radiation: hypofractionated radiation therapy; Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.; Radiation: image-guided radiation therapy; Image guided radiation therapy targets the specific site of disease.; Radiation: 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.

Outcome Measures

Primary Outcome Measures

1. 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease [6 months]

   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.

Secondary Outcome Measures

1. Number of Participants With Adverse Events [9 months, 11 days]

   Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

2. Median Time to Local Progression [6-12 months]

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

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

   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.

4. Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis [One to three months of followup]

   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.

5. Pain at Sites of Metastases [One and three months of follow up]

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

6. Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy [Baseline and prior to termination of systemic therapy or protocol withdrawal]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Deborah E. Citrin, MD, NCI - Radiation Oncology Branch; ROB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Citrin, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT00550654
• Other Study ID Numbers: 070230; NCI-07-C-0230
• First Posted: Oct 30, 2007
• Last Update Posted: Jan 13, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Deborah Citrin, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC): 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
• Additional relevant MeSH terms: Melanoma; Sarcoma; Neoplasm Metastasis; Kidney Neoplasms

Study Results

Participant Flow

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	1 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.6 (NA)
Gender (Count of Participants)
Female	0 0%
Male	1 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	1 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	1 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

2. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame	9 months, 11 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	1
Number [Participants]	1 100%

3. Secondary Outcome

Title	Median Time to Local Progression
Description	Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
Time Frame	6-12 months

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

4. Secondary Outcome

Title	12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

5. Secondary Outcome

Title	Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis
Description	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.
Time Frame	One to three months of followup

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

6. Secondary Outcome

Title	Pain at Sites of Metastases
Description	Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
Time Frame	One and three months of follow up

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

7. Secondary Outcome

Title	Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy
Description	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.
Time Frame	Baseline and prior to termination of systemic therapy or protocol withdrawal

Outcome Measure Data

Analysis Population Description

No data/specimens were collected. Study was terminated due to poor accrual.

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
Measure Participants	0

Adverse Events

Arm/Group Title	Radiation Therapy in Metastatic Cancer
Arm/Group Description	Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
All Cause Mortality
	Radiation Therapy in Metastatic Cancer
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Radiation Therapy in Metastatic Cancer
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Radiation Therapy in Metastatic Cancer
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Gastrointestinal disorders
Diarrhea	1/1 (100%)	1
Anorexia	1/1 (100%)	1
Taste alteration (dysgeusia)	1/1 (100%)	1
Nausea	1/1 (100%)	1
General disorders
Weight loss	1/1 (100%)	1
Fatigue (asthenia, lethargy, malaise)	1/1 (100%)	1
Musculoskeletal and connective tissue disorders
Pain::Buttock	1/1 (100%)	1
Pain::Extremity-limb	1/1 (100%)	1
Renal and urinary disorders
Urinary retention (including neurogenic bladder)	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates	1/1 (100%)	1
Hemorrhage, pulmonary/upper respiratory: Nose	1/1 (100%)	1
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)	1/1 (100%)	1
Rash/desquamation	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.