Adaptive Radiation Boost for Rectal Cancer

Korábbi kezelés

• Subjects who have been previously treated for rectal cancer are excluded.
• Subjects must not be receiving any other investigational agents.
• Subjects may not have had prior pelvic radiation.

Más betegség

• Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
• Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.
• Subjects must not have 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.
• Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).

Egyéb

• Subjects must not be pregnant or breast-feeding.

• Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
• Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.
• Subjects must be willing to undergo MRI scans.
• Age ≥18 years.
• ECOG performance status 0 or 1.
• Estimated survival of ≥ 12 months.
• Subjects must have normal organ and marrow function as defined below
  • Absolute neutrophil count > =1,000/mcL
  • Platelets >= 75,000/mcL
  • Total bilirubin < 3 mg/dL
• Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.
  • Before ART: Capecitabine at a dose of 825 mg/m²
  • After ART: FOLFOX combination chemotherapy, or 5-FU, or capecitabine
• Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.