Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01470365
3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors
A Phase 1 study testing quality-of-life assessment, intensity-modulated radiation therapy and 3-dimensional conformal radiation therapy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- quality-of-life assessment, intensity-modulated radiation therapy and 3-dimensional conformal radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2011to 21 Feb 2019
- 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
Who may be able to join
- Patients must have histologically-confirmed malignancy
- Patients must have recurrent or metastatic tumor located within a previously irradiated field
- Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
- Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, hormonal ,or other therapies
- Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
- Information on previous radiation treatment, including total dose and fractionation must be available; additional information including radiation fields and dose-volume-histogram or isodose lines is preferable
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- Tumor sites eligible for inclusion on this protocol include thorax, abdomen, and pelvis
- Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in the previously irradiated field
- Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
- Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelets (PLT) >= 75,000/ul
- Subjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up
Who cannot join
- Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
- Concurrent chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- For abdominal or pelvic irradiation: active inflammatory bowel disease
- Serious, active infections requiring treatment with intravenous (IV) antibiotics
- Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
- Reirradiation targets located within the head, neck, or brain are excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors
This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique.
SECONDARY OBJECTIVES:
- To investigate the dosimetric tolerance of normal structures to reirradiation with the pulsed low dose rate technique.
II. To determine the palliative efficacy and quality of life in patients treated on this protocol.
III. To determine duration of response and time to progression.
OUTLINE: This is a dose-escalation study.
Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month for 6 months and then every 12 weeks thereafter.
- Being tested
- quality-of-life assessment, intensity-modulated radiation therapy, 3-dimensional conformal radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo IMRT
3-dimensional conformal radiation therapyRadiation
Also called 3D conformal radiation therapy, 3D-CRT
Undergo 3-dimensional CRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo 3-dimensional CRT or IMRT QD, 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Procedure: quality-of-life assessment; Radiation: intensity-modulated radiation therapy; Radiation: 3-dimensional conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of reirradiation with the pulsed low dose rate technique
Defined as the dose level closest to, but not over that which is predicted to result in a dose limiting toxicity (DLT) rate of 20%, the target toxicity rate. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is a grade >= 4 acute or grade >= 3 late toxicity of an organ system within the reirradiation field in the following categories: skin or subcutaneous tissues, gastrointestinal, hepatobiliary, nervous system, renal and urinary, reproductive system, vascular, or respiratory, thoracic and mediastinal disorders.
Measured: Up to 30 days
Secondary outcomes (3)
Palliative efficacy in terms of quality of life and pain levels
Assessed using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) and the Numeric Pain Scale. The mean and standard deviation will be estimated at each time point.
Measured: Up to 3 years
Duration of response
Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.
Measured: Up to 3 years
Time to progression
Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study start3 Nov 2011
- Primary completion31 Aug 2015
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C-M Charlie Ma, PhD, Principal investigator, Fox Chase Cancer CenterJosphua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470365
- Sponsor's protocol ID
- OER-RT-042
- Other IDs
- NCI-2011-03311, IRB#11-044/OER-RT-042
- Status last verified
- May 2020
- First submitted
- 3 Nov 2011
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors
- ClinicalTrials.gov ID
- NCT01470365
- Acronym / sponsor ID
- OER-RT-042
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 3 Nov 2011 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 11 Nov 2011 (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.
This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique.
SECONDARY OBJECTIVES:
- To investigate the dosimetric tolerance of normal structures to reirradiation with the pulsed low dose rate technique.
II. To determine the palliative efficacy and quality of life in patients treated on this protocol.
III. To determine duration of response and time to progression.
OUTLINE: This is a dose-escalation study.
Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month for 6 months and then every 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Procedure: quality-of-life assessment, Radiation: intensity-modulated radiation therapy, Radiation: 3-dimensional conformal radiation therapyPatients undergo 3-dimensional CRT or IMRT QD, 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically-confirmed malignancy
- Patients must have recurrent or metastatic tumor located within a previously irradiated field
- Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
- Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, hormonal ,or other therapies
- Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
- Concurrent chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- For abdominal or pelvic irradiation: active inflammatory bowel disease
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 |
|---|---|---|
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Treatment (radiation therapy) |
| intensity-modulated radiation therapyAlso: IMRTUndergo IMRT | Radiation | Treatment (radiation therapy) |
| 3-dimensional conformal radiation therapyAlso: 3D conformal radiation therapy, 3D-CRTUndergo 3-dimensional CRT | Radiation | Treatment (radiation therapy) |
Primary outcome
MTD of reirradiation with the pulsed low dose rate technique
Time frame: Up to 30 days
Defined as the dose level closest to, but not over that which is predicted to result in a dose limiting toxicity (DLT) rate of 20%, the target toxicity rate. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is a grade >= 4 acute or grade >= 3 late toxicity of an organ system within the reirradiation field in the following categories: skin or subcutaneous tissues, gastrointestinal, hepatobiliary, nervous system, renal and urinary, reproductive system, vascular, or respiratory, thoracic and mediastinal disorders.
3 secondary outcomes
Palliative efficacy in terms of quality of life and pain levels
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Time to progression
Time frame: Up to 3 years
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 8 May 2020.
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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.
C-M Charlie Ma, PhD principal investigator
Fox Chase Cancer Center
Josphua Meyer, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quality-of-life assessment, intensity-modulated radiation therapy and 3-dimensional conformal radiation therapy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Fox Chase Cancer Center 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?
The sponsor lists 13 inclusion and 8 exclusion criteria. 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 8 May 2020. 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 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?
MTD of reirradiation with the pulsed low dose rate technique (time frame: Up to 30 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 8 May 2020.