Image Guided Radiation Therapy with MRI for the Treatment of Cancer, CONFIRM Study

Inclusion Criteria

• Participants must have histologically or cytologically confirmed malignancy requiring radiation
• Age 18 years or older (10 years or older for pediatric cohort)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Ability to understand and the willingness to sign a written informed consent document
• Any further criteria listed in the specific disease site cohort
• GASTRIC COHORT: Histologically or cytologically confirmed T3/T4 or N+ (> 1 cm in size or fludeoxyglucose F-18 [FDG]-avid) gastric cancer. Diagnosis must be confirmed by a Dana-Farber/Harvard Cancer Center (DF/HCC) institution pathology department prior to registration
• GASTRIC COHORT: Creatinine =< 1.5 x upper limit of normal or creatinine clearance >= 30 mL/min/1.73 m^3 for participants with creatinine levels above institutional normal
• GASTRIC COHORT: Ability to understand and the willingness to sign a written informed consent document
• BREAST COHORT: Pathologically confirmed invasive or in situ breast cancer. Diagnosis must be confirmed by a DF/HCC institution pathology department prior to registration
• BREAST COHORT: Treated with breast conserving surgery with negative margins, with tumor bed clips either: * Omitted by the treating surgeon, or * Not accurate, as determined by the treating radiation oncologist
• BREAST COHORT: Tumor in which adjuvant whole breast radiotherapy and in which tumor bed boost is clinically indicated, as determined by the following: * Invasive breast cancer in a patient age less than or equal to 50 with any grade tumor, or age 51-70 with high grade OR * Ductal breast carcinoma in situ (DCIS) with age less than or equal to 50, or high grade, or close < 2 mm margins, or any combination of those criteria
• BREAST COHORT: Women. Men are excluded due to the relative rarity of male breast cancer and difficulty in treating with breast conserving surgery (BCS) in men
• BREAST COHORT: Ability to understand and the willingness to sign a written informed consent document
• GENERAL LYMPHOMA COHORT: Participants must have histologically or cytologically confirmed lymphoma
• GENERAL LYMPHOMA COHORT: Age 18 years or older
• GENERAL LYMPHOMA COHORT: ECOG performance status =< 2
• GENERAL LYMPHOMA COHORT: Life expectancy of greater than 3 months
• GENERAL LYMPHOMA COHORT: Ability to understand and follow the breathing instructions involved in the respiratory gating procedure
• GENERAL LYMPHOMA COHORT: Ability to understand and the willingness to sign a written informed consent document
• BLADDER COHORT: Histologically confirmed transitional cell (urothelial) carcinoma of the bladder that is invasive into the muscularis propria (>= T2 disease) with or without radiographically or pathologically involved pelvic or common iliac lymph nodes (N0-N3). The presence of one or more variant histologies (squamous, adenocarcinoma, micropapillary, etc.) is allowed. Note: A prior diagnosis of non-muscle-invasive bladder cancer (=< T1) managed with transurethral resection with or without intravesicular therapy is allowed
• LARYNX COHORT: Biopsy proof of squamous cell carcinoma of the glottic larynx
• LARYNX COHORT: Undergoing definitive radiation for larynx cancer (not adjuvant)
• LARYNX COHORT: Stage Tis-T2N0M0 disease
• LARYNX COHORT: Smoking =< 1 pack per day
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Pathological diagnosis of extracranial solid tumors or lymphoma. Diagnosis must be confirmed by a DF/HCC institution pathology department prior to registration
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Patients must be under the age of 30 years
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Ability to understand and the willingness to sign a written informed consent document if the patient is over the age of 18 years; for children over the age of 10 years and under age of 18 years, ability to understand and willingness to assent to treatment; and for children under the age of 18 years, parent(s) must have the ability to understand and willingness to sign a written informed consent document
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Radiation field size must be compatible with the maximum MR-Linac field size.
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Patient tolerates breath-holding if required based on location of the tumor
• LUNG SPARE COHORT: Must have biopsy-proven or clinically suspected malignancy within the lung
• LUNG SPARE COHORT: Lesions must be in the peripheral lung, defined as > 1 cm from the proximal bronchial tree and mediastinal pleura
• LUNG SPARE COHORT: Lesions must be < 5 cm in maximum diameter
• LUNG SPARE COHORT: Lesions must be expected to have > 1 cm of respiratory motion craniocaudally as determined by a clinician (assessed based on tumor location/proximity to the diaphragm) or shown to have > 1 cm respiratory motion from prior simulation

Exclusion Criteria

• History of allergic reactions attributed to gadolinium-based intravenous (IV) contrast * Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
• Severe claustrophobia or anxiety
• Participants who cannot undergo an MRI
• Any other exclusion criteria listed in the specific disease site cohort
• GASTRIC COHORT: Evidence of metastatic or distant nodal disease as determined by chest CT scan, abdomen/pelvis CT scan, PET/CT, or MRI with gadolinium and/or manganese) within six weeks of study entry
• GASTRIC COHORT: Any prior radiation for treatment of participant’s gastric cancer
• GASTRIC COHORT: Known hypersensitivity to fluorouracil (5-FU) or known deoxypyridinoline (DPD) deficiency
• GASTRIC COHORT: Implanted MRI-incompatible devices, such as MRI-incompatible cardiac implantable electronic devices or ferromagnetic orthopedic hardware
• BREAST COHORT: Clinical or radiographic evidence of metastatic or distant nodal disease as determined by chest CT scan, abdomen/pelvis CT scan (or MRI with gadolinium and/or manganese) within six weeks of study entry. Screening imaging for metastasis will not be mandated by the study
• BREAST COHORT: Radiation to the breast or thorax prior to study entry
• BREAST COHORT: Breast tumor bed not visualized at CT or MRI during RT planning
• BREAST COHORT: Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• BREAST COHORT: Implanted MRI-incompatible devices, such as MRI-incompatible cardiac implantable electronic devices or orthopedic hardware
• GENERAL LYMPHOMA COHORT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• GENERAL LYMPHOMA COHORT: Pregnant women are excluded from this study
• GENERAL LYMPHOMA COHORT: Severe claustrophobia or anxiety
• GENERAL LYMPHOMA COHORT: Unable to undergo magnetic resonance imaging (MRI) due to any of the following: * Presence of MRI-incompatible metal material or devices in the human body * MRI-incompatible Pacemaker or defibrillator * Insulin pump * Aneurysm clip * Artificial heart valve * Cochlear implant * Shrapnel or gunshot injury * Cataract surgery with implant unsafe for MRI
• BLADDER COHORT: Prior pelvic radiation
• BLADDER COHORT: Evidence of metastatic disease on CT of the chest, abdomen, and pelvis. PET/CT can be considered in patients with renal dysfunction who are unable to receive IV contrast
• BLADDER COHORT: Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• LARYNX COHORT: Inability to lie still for approximately 1 hour in immobilization device
• LARYNX COHORT: Inability to develop a radiation treatment plan that adheres to the dose constraints
• LARYNX COHORT: < 4 weeks from recent larynx surgery (may be enrolled prior to 4 weeks but may not be treated until 4 weeks from surgery)
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Patient requiring anesthesia for simulation or treatment are excluded
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Implanted MRI-incompatible devices, such as MRI-incompatible cardiac implantable electronic devices or ferromagnetic orthopedic hardware
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Location of the tumor is within the central nervous system
• PEDIATRIC EXTRACRANIAL SOLID TUMORS AND LYMPHOMA COHORT: Patient enrolled on a Children's Oncology Group (COG) trial that would preclude treatment on MR-linac