RECRUITING

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX

Quick Facts

Study Start:2021-02-11
Study Completion:2026-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04703101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed rectal adenocarcinoma
  2. * Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
  3. * No evidence of metastatic disease
  4. * Resectable primary lesion
  5. * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
  6. * Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3
  7. * Hemoglobin (Hgb) \> 8.0 gm/dL
  8. * Platelets (PLT) \> 150,000/mm\^3
  9. * Total bilirubin \< or equal to 1.5 x upper limit of normal
  10. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or equal to three times upper limit of normal
  11. * If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy
  1. * Active treatment of a separate malignancy
  2. * 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
  3. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  4. * Pregnant and/or breastfeeding
  5. * Medical/psychological contraindication to MRI

Contacts and Locations

Study Contact

Vincent Basehart
CONTACT
310 267-8954
vbasehart@mednet.ucla.edu

Principal Investigator

Ann Raldow
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Ann Raldow, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-11
Study Completion Date2026-10-15

Study Record Updates

Study Start Date2021-02-11
Study Completion Date2026-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Rectal Carcinoma
  • Rectal Adenocarcinoma
  • Stage II Rectal Cancer AJCC v8
  • Stage IIA Rectal Cancer AJCC v8
  • Stage IIB Rectal Cancer AJCC v8
  • Stage IIC Rectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8