High dose re-irradiation for solid tumors using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial focuses on a standardized approach to re-irradiation for patients with solid tumors, utilizing advanced deformable image registration and individualized dose calculations for organs at risk. The study aims to assess the toxicity rates associated with re-irradiation across various critical organs, including the spinal cord and gastrointestinal tract. A total of 120 patients will be treated, with a specific focus on monitoring and analyzing the incidence of Grade 3-5 toxicities. The goal is to ensure precise and safe re-irradiation while minimizing risks to surrounding healthy tissues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed informed consent
2. Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s).
3. Prior radiation dosimetry must be available.
4. 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 reports are required. Local review of pathology or cytology is at the discretion of the multidisciplinary team.
5. Histologic confirmation of target lesion recurrence is recommended.
6. Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated.
7. Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale.
8. Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable.
9. 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.
10. 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 eligible for study.
11. Measurable disease is not required for patients being treated postoperatively.
12. 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 other OAR function). Recommended labs and values include:

    * 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 \< 1.5 x ULN or Creatinine clearance \> 45 mL/min if creatinine is \> 1.5 x ULN (calculated Creatinine Clearance (CrCl) based on Cockcroft-Gault equation)
13. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
14. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.
15. Life expectancy of at least 6 months.
16. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.
17. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).
18. Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.

Exclusion Criteria:

1. Patients receiving low dose radiation for symptom management only.
2. Patients with evidence of severe or uncontrolled systemic conditions.
3. Life expectancy of less than 6 months.
4. ECOG Performance status ≥ 3.
5. 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

Where it's running

• Froedtert Hospital
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Gore, MD — Medical College of Wisconsin
• Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office
• Email: cccto@mcw.edu
• Phone: 866-680-0505

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1

  This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.

  Recruiting at 2 sites Phase 1 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shenyang, Liaoning and 1 other locations · NCT07830199

• FAPI PET imaging with FAPI-RuiJ and FAPI-04 in solid tumors

  This study tests two FAP-targeted PET tracers (FAPI-RuiJ and FAPI-04) to see which better detects, stages, and monitors solid tumors.

  Recruiting Ruijin Hospital · Shanghai · NCT07776899

• Trop-2 Targeted PET/CT for Recurrent and Metastatic Thyroid Cancer

  This study tests whether a Trop-2 targeted PET/CT scan can better detect recurrent or metastatic thyroid cancer in adults than another PET/CT scan (FAPI).

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07753499

• SI-B036 in locally advanced or metastatic breast cancer and other solid tumors

  Scientists are testing SI-B036 to see if it is safe and tolerable in adults with advanced breast cancer or other solid tumors and to get early signals of whether it might help.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07753226

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.