Adaptive Radiotherapy for Rectal Cancer

(ARBOR Trial)

JM
JH
Overseen ByJianli Hu, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Fox Chase Cancer Center
Must be taking: Capecitabine, FOLFOX
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an extra dose of radiation, adjusted to tumor response, can enhance rectal cancer treatment and reduce side effects. After standard radiation and chemotherapy, participants receive additional radiation (adaptive radiotherapy boost) fine-tuned with MRI scans and a small balloon to protect healthy tissue. It targets individuals with specific stages of rectal cancer who have not undergone prior treatments. Participants should be comfortable with MRI scans and able to handle chemotherapy before and after the test phase. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this adaptive radiotherapy is safe for rectal cancer patients?

Research has shown that adaptive radiotherapy, which adjusts treatment using MRI scans, is generally safe for patients. Studies have found that this method carries a low risk of severe side effects, making serious negative reactions uncommon.

One study discovered that higher doses of radiation in adaptive radiotherapy have a favorable side-effect profile, indicating that most patients did not experience severe negative reactions.

These findings suggest that patients tolerate adaptive radiotherapy well. It can target cancer cells more precisely without causing significant harm to nearby healthy tissue.12345

Why are researchers excited about this trial?

Adaptive Radiotherapy Boost is unique because it personalizes radiation treatment for rectal cancer patients in a way that standard therapies do not. Traditional radiotherapy often uses a fixed plan for all patients, but adaptive radiotherapy adjusts the radiation dose and delivery based on real-time changes in the tumor and surrounding tissues. Researchers are excited about this approach because it has the potential to increase the precision and effectiveness of treatment, potentially reducing side effects and improving outcomes for patients.

What evidence suggests that adaptive radiotherapy might be an effective treatment for rectal cancer?

Research has shown that adaptive radiotherapy, which adjusts radiation doses based on tumor response, could effectively treat rectal cancer. In this trial, participants will receive an Adaptive Radiotherapy Boost after standard pelvic chemoradiation. One study found a promising complete response rate of 27%, meaning no detectable cancer, due to higher radiation doses, with manageable side effects. This method targets aggressive cancer cells while protecting healthy tissue. By using regular MRI scans to adjust treatment, adaptive radiotherapy aims to improve accuracy and reduce unwanted side effects.46789

Who Is on the Research Team?

JM

Joshua Meyer

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with rectal cancer who have already undergone standard chemoradiation. They must be able to undergo MRI scans and use a small balloon device during treatment. Specific details on inclusion and exclusion criteria are not provided, but typically participants need to meet certain health standards.

Inclusion Criteria

I can understand and am willing to sign the informed consent and HIPAA documents.
Subjects must be willing to undergo MRI scans
Estimated survival of ≥ 12 months
See 6 more

Exclusion Criteria

Subjects receiving other investigational agents
Subjects with uncontrolled intercurrent illness
Subjects who are pregnant or breast-feeding
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Chemoradiation Treatment

Participants receive standard radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine

5 weeks

Adaptive Radiation Boost

Participants receive extra radiation using MRI scans every two weeks to adjust the treatment based on tumor response

5 weeks

Additional Chemotherapy

Participants receive additional chemotherapy (such as FOLFOX) for four months

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adaptive Radiotherapy Boost
Trial Overview The study tests if adding an adaptive radiation boost after standard chemoradiation can more precisely target aggressive cancer cells in rectal cancer patients while sparing healthy tissue. It involves MRI-guided adjustments every two weeks and additional chemotherapy post-radiation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Adaptive Radiotherapy Boost Following Standard Pelvic ChemoradiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Varian Medical Systems

Industry Sponsor

Trials
63
Recruited
3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Citations

Radiotherapy boost to the primary tumour in locally ...This systematic review and meta-analysis investigate the technical parameters used for rectal boost RT and assess their impact on oncological ...
On the trail of CBCT-guided adaptive rectal boost ...This study aims to compare and quantify the inter-operator and inter-professional delineation variability of the rectal boost volume on CBCT.
Adaptive radiation dose escalation in rectal adenocarcinomaResults were promising with a pCR rate of 27%, attributed by the authors to the high doses of radiation used, with a favorable side-effect profile consisting of ...
Daily Online Adaptive Radiotherapy for Rectal Cancer ...This study reports on the feasibility and toxicities of oART for rectal cancer with a CT-Linac and analyzes the optimal margins needed.
Adaptive Boost Radiotherapy to Primary Lesions and ...This is a multicenter, randomized, controlled phase III trial to evaluate the efficacy and safety of adaptive boost radiotherapy to the primary lesions and ...
Efficacy and safety of MR-guided adaptive simultaneous ...The objective of this study is to evaluate the efficacy and safety of MRgART dose escalation to both primary lesions and positive lymph nodes.
NCT07221058 | Adaptive Radiation Boost for Rectal CancerThe goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and ...
Review Article Radiotherapy boost to the primary tumour in ...Several teams have already implemented online-adaptive RT for rectal cancers, showing promising findings regarding PTV reduction and dosimetric results [[125], ...
Safety and Tolerability of Online Adaptive High-Field ...The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.
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