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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04703101
Phase
PHASE1
Status
Recruiting
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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
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Leucovorin — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Surveillance — BEHAVIORAL
    Undergo NOM
  • Total Mesorectal Excision — PROCEDURE
    Undergo TME

Study Details

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.

Key Dates

Start date
Feb 11, 2021
Status verified
Mar 2026
Primary completion
Oct 1, 2026
Completion
Oct 15, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Ann Raldow
[email protected]
310-825-9771
Ann Raldow (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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