Ultra-fractionated Radiotherapy for Rectal Cancer

NCT ID: NCT04677413

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2026-06-30

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.

Detailed Description

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.

Conditions

Rectal Cancer

Study Design

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

Study Groups

Phase I Dose Cohorts

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)

Group Type: EXPERIMENTAL

Ultrafractionated radiotherapy for rectal cancer

Intervention Type: 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.

Interventions

Ultrafractionated radiotherapy for rectal cancer

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.

Intervention Type: RADIATION

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

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

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nina Sanford

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nina Sanford, MD

Role: PRINCIPAL_INVESTIGATOR

UT SOUTHWESTERN medical CENTRE

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Busayo Adefalujo

Role: CONTACT

busayo.adefalujo@utsouthwestern.edu

12146458525

Sarah Neufeld

Role: CONTACT

sarah.hardee@utsouthwestern.edu

12146458525

Facility Contacts

sarah Hardee

Role: primary

sarah.neufeld@UTSouthwestern.edu

12146458525

Other Identifiers

2020-1394

Identifier Type: -

Identifier Source: org_study_id