Ultra-fractionated radiotherapy for rectal cancer treatment

Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer

This study is testing a new way to treat locally advanced rectal cancer using a higher dose of short radiation therapy combined with chemotherapy to see if it can help patients avoid surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT04677413 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the feasibility of a non-operative management approach for locally advanced rectal cancer by using dose-escalated ultra-fractionated short course radiation therapy combined with chemotherapy. The study will determine the maximal tolerated dose of this treatment regimen in patients with rectal adenocarcinoma classified as T3-4 or N+. Participants will receive either FOLFOX or CAPOX chemotherapy alongside the radiation therapy, with the goal of improving clinical response while potentially omitting surgery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a pathologic diagnosis of rectal adenocarcinoma classified as T3-4 or N+.

Not a fit: Patients who have previously received treatment for rectal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with locally advanced rectal cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the use of hypofractionated radiation therapy combined with chemotherapy for rectal cancer.

Eligibility criteria

Inclusion Criteria:

1. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
2. Willing and able to provide written informed consent
3. Pathologic diagnosis of rectal adenocarcinoma
4. T3-4 and/or N+ disease per AJCC 8th edition
5. No prior treatment for rectal adenocarcinoma
6. Eastern Cooperative Group (ECOG) performance status of 0-2.
7. Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows:

   * WBC ≥ 3,000/mL;
   * ANC WBC ≥ 1,000/mL;
   * PLT ≥ 75,000/mL;
   * T Bili ≤ 1.5 x upper limit of normal (ULN);
   * AST/ALT ≤ 2.5 x ULN;
   * Creatinine not above ULN, or creatinine clearance \>50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal.
8. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
2. Prior RT to the pelvis.
3. Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
4. Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
5. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Nina Sanford, MD — UT SOUTHWESTERN medical CENTRE
• Study coordinator: Busayo Adefalujo

Conditions Rectal Cancer; Rectal Cancer,T3-4 or N+