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RecruitingNCT07221058ARBORUpdated Dec 9, 2025

Adaptive Radiation Boost for Rectal Cancer

A Phase 1 interventional study of Adaptive Radiotherapy Boost in Rectum Cancer, Adenocarcinoma, sponsored by Fox Chase Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Fox Chase Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.

The main questions the study aims to answer are:

  • Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue?
  • Can it reduce the side effects that people may experience during treatment?

Participants will:

  • First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine.
  • Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds.
  • Use a small balloon during treatment to help aim the radiation and protect healthy areas.
  • Finally, receive additional chemotherapy (such as FOLFOX) for four months.
02

Conditions studied

  • Rectum Cancer, Adenocarcinoma

Keywords

  • Adaptive Radiation Therapy
  • Rectum Cancer
  • Adenocarcinoma
  • Organ Preservation
  • Total Mesorectal Excision
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 37 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • Experimental
    Adaptive Radiotherapy Boost Following Standard Pelvic Chemoradiation

    Adaptive Radiotherapy

    Radiation: Adaptive Radiotherapy Boost

Interventions

  • RadiationAdaptive Radiotherapy Boost

    Patients will receive one boost fraction every two weeks, targeting the primary tumor within the rectum plus a 2 mm Planning Target Volume (PTV) margin. Any regional lymph nodes that measure at least 5 mm in short axis on the day of treatment will receive treatment with the ART dose being given to the primary rectal tumor.

06

What researchers measure

Primary outcomes

  1. MTD will be evaluated by monitoring the rate of dose limiting toxicities (DLTs) defined as acute Grade 2+ gastrointestinal toxicity probably or definitely related to radiation.

    Time frame: From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days.

  2. Feasibility of a rectal boost that targets at least 90% of the rectal planning tumor volume with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc.

    Feasibility will be determined based on successful implementation and completion of standard chemoradiotherapy followed by experimental rectal adaptive radiotherapy boost utilizing CT-MR fusion that targets at least 90% of the rectal PTV\_Eval with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc in ≥ 70% of ART fractions for the patient population enrolled in the study. This will be assessed at the MTD.

    Time frame: From the ART boost initiation to the end of the ART boost, for a period of ~ 5 weeks

Secondary outcomes

  1. Estimate the efficacy of bi-weekly adaptive radiotherapy boost fractions by complete response rate, near complete response rate, and incomplete response rate as per Memorial Sloan Kettering Cancer Center (MSKCC) criteria.

    Time frame: From the end of rectal adaptive radiotherapy boost to the end of study, for a total of ~ 5 years.

  2. Estimate total mesorectal excision (TME) free survival following treatment with the study regimen.

    Time frame: From the end of treatment to the end of the study, for a total of up to 5 years.

  3. Estimate overall survival (OS) following treatment with the study regimen.

    Time frame: From the end of treatment to the end of study, for a total of up to 5 years.

  4. Estimate early and late toxicity following treatment with the study regimen.

    Time frame: From the initiation of rectal radiation boost treatment to the end of the study, for a total of ~ 5 years.

07

Study locations

1 of 1 sites recruiting
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07221058
Lead sponsor
Fox Chase Cancer Center
Collaborators
Varian Medical Systems
Responsible party
Sponsor
First posted
Oct 27, 2025
Start date
Oct 24, 2025
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2029 (estimated)
Last update
Dec 9, 2025

Study contacts

Joshua Meyer, MD
Contact
Joshua.Meyer@fccc.edu
215-728-2667
Jianli Hu, MD, PhD
Contact
Jianli.Hu@fccc.edu
267-449-1431
Joshua Meyer
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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