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

ConditionsLocally Advanced Rectal CarcinomaRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    Ancillary studies

  • Surveillance

    Behavioral

    Undergo NOM

  • Total Mesorectal Excision

    Procedure/Surgery

    Undergo TME

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (IMRT, mFOLFOX6, CapeOX, TME)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Complete clinical response rate

Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the non-operational management (NOM) and total mesorectal excision (TME) cohorts separately.

Time frame
Up to 5 years

Secondary outcomes

1

Local recurrence-free survival

Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the NOM and TME cohorts separately.

Time frame
At 1 year
2

Progression-free survival

Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the NOM and TME cohorts separately.

Time frame
At 1 year
3

Incidence of adverse events

Physician-reported acute and late \>= grade 3 toxicity rates for the entire cohort will be graded according to Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 5 years
4

Health-related quality of life

Will be assessed by Patient Reported Outcomes Measurement and Information System and calculated and presented as a composite score. These scores will be calculated for the entire cohort as well as the NOM and TME cohorts separately.

Time frame
At 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

The Joseph Drown Foundation

Collaborator

Natera, Inc.

Collaborator

Source ClinicalTrials.gov
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