Adaptive radiation boost to try to preserve the rectum in people with rectal adenocarcinoma

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 Phase 1 interventional protocol gives standard long-course chemoradiation (45 Gy in 25 fractions with concurrent capecitabine) followed by an adaptive radiation boost guided by repeat MRI scans every two weeks. During boost treatments an intrarectal balloon is used to stabilize and protect nearby tissue while the boost plan is modified based on tumor response. After radiation, patients receive additional systemic chemotherapy such as FOLFOX for about four months. The primary aim is to determine the safety and feasibility of MRI-guided adaptive boosting and its ability to concentrate dose on residual tumor while reducing exposure to normal organs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
2. 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.
3. Subjects must be willing to undergo MRI scans.
4. Age ≥18 years.
5. ECOG performance status 0 or 1.
6. Estimated survival of ≥ 12 months.
7. 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
8. 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
9. 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.

Exclusion Criteria:

1. Subjects who have been previously treated for rectal cancer are excluded.
2. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
3. Subjects must not be receiving any other investigational agents.
4. Subjects may not have had prior pelvic radiation.
5. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.
6. 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.
7. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).
8. Subjects must not be pregnant or breast-feeding.

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Joshua Meyer — Fox Chase Cancer Center
• Study coordinator: Joshua Meyer, MD
• Email: Joshua.Meyer@fccc.edu
• Phone: 215-728-2667

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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.