Adaptive Radiation Boost for Rectal Cancer

NCT ID: NCT07221058

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2029-11-01

Brief 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.

Conditions

Rectum Cancer, Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive Radiotherapy Boost Following Standard Pelvic Chemoradiation

Adaptive Radiotherapy

Group Type: EXPERIMENTAL

Adaptive Radiotherapy Boost

Intervention Type: RADIATION

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.

Interventions

Adaptive 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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Meyer

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua Meyer, MD

Role: CONTACT

Joshua.Meyer@fccc.edu

215-728-2667

Jianli Hu, MD, PhD

Role: CONTACT

Jianli.Hu@fccc.edu

267-449-1431

Facility Contacts

Joshua Meyer, MD

Role: primary

Joshua.Meyer@fccc.edu

267-449-1431

Jianli Hu, MD, PhD

Role: backup

Jianli.Hu@fccc.edu

2674491431

Other Identifiers

25-1024

Identifier Type: OTHER

Identifier Source: secondary_id

RT-231

Identifier Type: -

Identifier Source: org_study_id