Ultra-fractionated Radiotherapy for Rectal Cancer

NCT04677413 | Recruiting Phase 1 DMC

• 1 other identifier: 2020-1394
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.

Conditions

Rectal Cancer

Keywords

Rectal Cancer,T3-4 or N+

Outcome Measures

Primary Outcomes (1)

• To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.

  The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.

  0 to 60 days post radiation therapy

Secondary Outcomes (6)

• To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy.

  1 year

• To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy.

  1 year

• To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression.

  1 year

• To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death.

  1 year

• For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.

  1 year

Study Arms (1)

Phase I Dose Cohorts

EXPERIMENTAL

DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)

Radiation: Ultrafractionated radiotherapy for rectal cancer

Interventions

Ultrafractionated radiotherapy for rectal cancer RADIATION

To determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery.

Phase I Dose Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
• Willing and able to provide written informed consent
• Pathologic diagnosis of rectal adenocarcinoma
• T3-4 and/or N+ disease per AJCC 8th edition
• No prior treatment for rectal adenocarcinoma
• Eastern Cooperative Group (ECOG) performance status of 0-2.
• 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.
• 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:

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8849, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nina Sanford, MD

  UT SOUTHWESTERN medical CENTRE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Busayo Adefalujo

CONTACT

12146458525; busayo.adefalujo@utsouthwestern.edu

Sarah Neufeld

CONTACT

12146458525; sarah.hardee@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective dose evaluation

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: June 3, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)