Metastatic CancerPhase 1NCT00255814
Radiation Therapy in Treating Patients With Liver Metastases
A Phase 1 study testing radiation therapy in people with Metastatic Cancer, run by Radiation Therapy Oncology Group at 3 sites in 2 countries.
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 I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2005to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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:
- Diagnosis of 1 of the following:
- Histologically confirmed non-lymphoma liver metastases
- New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver
- No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan
- Liver metastases ≤ 8 cm
- Medically unfit for surgery OR lesions are surgically unresectable
- All intrahepatic disease must be encompassed within the study radiation field
- Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting
- At least 1,000 cc of normal liver
- No clinical ascites
- No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
- No active hepatitis
- No clinically significant liver failure
- No underlying cirrhosis
Renal
- Not specified
Cardiovascular
- No congestive heart failure requiring hospitalization within the past 6 months
- No unstable angina pectoris requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
Pulmonary
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis
- No acute bacterial or fungal infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)
Radiotherapy
- No prior radiotherapy to the region of study
- No concurrent intensity-modulated radiotherapy
Surgery
- Prior liver resection or ablative therapy allowed
Other
- No concurrent warfarin or IV heparin
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
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 I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.
Secondary
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.
- Determine the local control rate within irradiated fields in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study.
Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.
Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
- Conditions
- Metastatic Cancer
- Being tested
- radiation therapy
- Keywords
- liver metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy dose level II: 4.0 Gy/fx | Other | Radiation therapy dose level II: 4.0 Gy/fraction Receives: Radiation: radiation therapy |
| Radiation therapy dose level III: 4.5 Gy/fx | Other | Radiation therapy dose level III: 4.5 Gy/fraction Receives: Radiation: radiation therapy |
| Radiation therapy dose level IV: 5.0 Gy/fx | Other | Radiation therapy dose level IV: 5.0 Gy/fraction Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximally tolerated dose
Measured: From start of treatment to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alan W. Katz, MD, Principal investigator, James P. Wilmot Cancer CenterLaura A. Dawson, MD, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255814
- Sponsor's protocol ID
- RTOG-0438
- Other IDs
- CDR0000450766
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2005
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
- ClinicalTrials.gov ID
- NCT00255814
- Acronym / sponsor ID
- RTOG-0438
- Conditions
- Metastatic Cancer
- Keywords
- liver metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.
Secondary
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.
- Determine the local control rate within irradiated fields in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study.
Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.
Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy dose level II: 4.0 Gy/fx | Other | Radiation: radiation therapyRadiation therapy dose level II: 4.0 Gy/fraction |
| Radiation therapy dose level III: 4.5 Gy/fx | Other | Radiation: radiation therapyRadiation therapy dose level III: 4.5 Gy/fraction |
| Radiation therapy dose level IV: 5.0 Gy/fx | Other | Radiation: radiation therapyRadiation therapy dose level IV: 5.0 Gy/fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | Radiation therapy dose level II: 4.0 Gy/fx, Radiation therapy dose level III: 4.5 Gy/fx, Radiation therapy dose level IV: 5.0 Gy/fx |
Primary outcome
To determine the maximally tolerated dose
Time frame: From start of treatment to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan W. Katz, MD principal investigator
James P. Wilmot Cancer Center
Laura A. Dawson, MD study chair
Princess Margaret Hospital, Canada
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing radiation therapy in people with Metastatic Cancer, run by Radiation Therapy Oncology Group at 3 sites in 2 countries.
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: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximally tolerated dose (time frame: From start of treatment to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2015.