Recruiting
Phase 1

Radiation Therapy & Chemotherapy

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT04703101

Conditions

Locally Advanced Rectal Carcinoma

Rectal Adenocarcinoma

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Capecitabine

Fluorouracil

Intensity-Modulated Radiation Therapy

Leucovorin

Oxaliplatin

Study Details

Brief summary:

This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

Conditions

Locally Advanced Rectal Carcinoma

Rectal Adenocarcinoma

Stage II Rectal Cancer AJCC v8

Stage IIA Rectal Cancer AJCC v8

Stage IIB Rectal Cancer AJCC v8

Study ID

NCT04703101

Start date

Feb 11, 2021

Status verified date

Mar, 2026

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed rectal adenocarcinoma
  • Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
  • No evidence of metastatic disease
  • Resectable primary lesion
  • Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count (ANC) > 1.5 cell/mm\^3
  • Hemoglobin (Hgb) > 8.0 gm/dL
  • Platelets (PLT) > 150,000/mm\^3
  • Total bilirubin < or equal to 1.5 x upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to three times upper limit of normal
  • If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy

Exclusion Criteria:

  • Active treatment of a separate malignancy
  • Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Pregnant and/or breastfeeding
  • Medical/psychological contraindication to MRI

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (IMRT, mFOLFOX6, CapeOX, TME)

Patients undergo SCRT in the form of IMRT over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin IV and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine PO BID on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.

Interventions

Capecitabine

Given IV

Fluorouracil

Given IV

Intensity-Modulated Radiation Therapy

Undergo IMRT

Leucovorin

Given IV

Oxaliplatin

Given IV

Quality-of-Life Assessment

Ancillary studies

Surveillance

Undergo NOM

Total Mesorectal Excision

Undergo TME

Primary outcome measure

  • Complete clinical response rate [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Vincent Basehart

310 267-8954vbasehart@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ann Raldow

310-825-9771araldow@mednet.ucla.edu

Principal Investigator:

Ann Raldow

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-03-30.