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New treatment option for Solid Tumor
Official title High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis
ClinicalTrials.gov ID: NCT05301101
What this study is testing
- What it's testing
- This trial applies a uniform approach to re-irradiation for planning and diagnostic image fusion, dose summation, dose calculations, and follow up for tumor control and detailed toxicity analysis of serial Organs At Risk (OARs). Serial organs include named arteries and nerves, spinal cord, and gastrointestinal tract.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed informed consent
- Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s).
- Prior radiation dosimetry must be available.
- Participants must have stage I-IV biopsy proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either...
- Histologic confirmation of target lesion recurrence is recommended.
You likely can't join if
- Patients receiving low dose radiation for symptom management only.
- Patients with evidence of severe or uncontrolled systemic conditions.
- Life expectancy of less than 6 months.
- ECOG Performance status ≥ 3.
- Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed...
See the full eligibility criteria
- Provision of signed informed consent
- Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s).
- Prior radiation dosimetry must be available.
- Participants must have stage I-IV biopsy proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site). Documentation of pathology...
- Histologic confirmation of target lesion recurrence is recommended.
- Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated.
- Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale.
- Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable.
- Baseline target lesion imaging with CT, positron emission tomography (PET) /CT, or MRI is required within six weeks of trial enrollment. CT or MRI simulation scans may be used for baseline imaging.
- Patients who have had disease resected in a previously irradiated field and are at high pathological and clinical risk for recurrence as defined by the treating Radiation Oncologist and multidisciplinary team, are...
- Measurable disease is not required for patients being treated postoperatively.
- Baseline labs are per standard practice. Values will be dependent on the OARs being treated. (Per standard practice, radiation therapy volumes to OARs are modified to accommodate compromised renal, liver, pulmonary or...
- Aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN) or \< 5 x ULN with metastatic liver disease.
- Total bilirubin \< 1.5 x ULN
- Absolute neutrophil count (ANC) \> 500 cells/mm\^3
- Platelets \> 50,000 cells/mm\^3
- Creatinine \ 45 mL/min if creatinine is \> 1.5 x ULN (calculated Creatinine Clearance (CrCl) based on Cockcroft-Gault equation)
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
- Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.
- Life expectancy of at least 6 months.
- Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.
- Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).
- Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.
- Patients receiving low dose radiation for symptom management only.
- Patients with evidence of severe or uncontrolled systemic conditions.
- Life expectancy of less than 6 months.
- ECOG Performance status ≥ 3.
- Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.