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Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)

Primary Purpose

Adenocarcinoma of the Lower Rectum

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiation therapy

FOLFOX regimen

Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire

Rectal biopsy samples

Blood for ctDNA

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Lower Rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
Clinically detectable (MR, endoscopy, or DRE) tumor present
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 18 years of age
Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) > 1,500 cells/mm3
- Hemoglobin> 8 g/dl
- Platelets >100,000 cells/mm3
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria

Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
Prior oxaliplatin or capecitabine use for any malignancy
No prior radiation therapy to the pelvis.
A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
Currently receiving any investigational agents.
A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.

Sites / Locations

University of ColoradoRecruiting
Mayo ClinicRecruiting
Washington University School of MedicineRecruiting
University of Vermont Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation + FOLFOX

Arm Description

Pelvic radiotherapy 5GY x 5 fractions once daily Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). Oxaliplatin day 1 every 14 days Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. 5-FU bolus day 1 every 14 days 5-FU infusion day 1 every 14 days over 46 hours Alternatively CAPOX (capecitabine and oxaliplatin) may be given for 5 cycles over 15 weeks. An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Outcomes

Primary Outcome Measures

Clinical complete response rate

-Criteria for clinical complete response: No residual gross tumor at procto/sigmoidoscopy;, or only erythematous scar or ulcer No palpable tumor on DRE No radiographic evidence of tumor on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)

Secondary Outcome Measures

Progression-free survival (PFS)

Criteria for progressive disease *Increase in the size of primary tumor by RECIST criteria New metastatic disease

Incidence of grade 3 or higher toxicity during treatment

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Incidence of post chemoradiotherapy grade 3 or higher toxicity

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Quality of anorectal function as measured by the FACT-C questionnaire

Questionnaire with 5 sections (physical well-being, social/family well being, emotional well-being, functional well-being, and additional concerns) Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life the person has

Organ preservation rate

Full Information

NCT ID

NCT03904043

First Posted

April 3, 2019

Last Updated

August 13, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03904043

Brief Title

Non-Operative Management and Early Response Assessment in Rectal Cancer

Acronym

NOM-ERA

Official Title

Non-Operative Management and Early Response Assessment in Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Lower Rectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiation + FOLFOX

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Description

-Monday-Friday treatment is strongly recommended

Intervention Type

Drug

Intervention Name(s)

FOLFOX regimen

Intervention Description

-CAPOX can be given as alternative

Intervention Type

Other

Intervention Name(s)

Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire

Intervention Description

-Baseline, completion of chemotherapy (3-8 weeks after the end of chemotherapy), and 10 to 14 months after radiotherapy

Intervention Type

Procedure

Intervention Name(s)

Rectal biopsy samples

Intervention Description

-Multiple biopsy samples of the rectal tumor will be taken from the patient tumor prior to treatment initiation for genomic extraction. For patients at affiliate sites who do not have enough tissue from the diagnostic biopsy, a repeat pre-treatment biopsy is optional.

Intervention Type

Procedure

Intervention Name(s)

Blood for ctDNA

Intervention Description

-Prior to the start of treatment, Post radiation therapy labs (with standard of care (SOC) CBC/CMP prior to start of cycle 1 of chemotherapy), Day 1 of cycle 2 of chemotherapy (with SOC CBC/CMP), Completion of chemotherapy (3-8 weeks after the end of chemotherapy), months 3, 6, 9, 12, 16, 20, 24 until salvage surgery or 2 years from completion of chemotherapy (whichever is first)

Primary Outcome Measure Information:

Title

Clinical complete response rate

Description

Time Frame

Completion of treatment (estimated to be 22 weeks)

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Criteria for progressive disease *Increase in the size of primary tumor by RECIST criteria New metastatic disease

Time Frame

2 years

Title

Incidence of grade 3 or higher toxicity during treatment

Description

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Time Frame

Completion of treatment (estimated to be 22 weeks)

Title

Incidence of post chemoradiotherapy grade 3 or higher toxicity

Description

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Time Frame

1 year

Title

Quality of anorectal function as measured by the FACT-C questionnaire

Description

Time Frame

1 year (between 10-14 months post treatment start date)

Title

Organ preservation rate

Time Frame

1 year

Title

Organ preservation rate

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy Clinically detectable (MR, endoscopy, or DRE) tumor present Eastern Cooperative Oncology Group (ECOG) performance status 0-2 At least 18 years of age Adequate bone marrow function defined as: Absolute neutrophil count (ANC) > 1,500 cells/mm3 Hemoglobin> 8 g/dl Platelets >100,000 cells/mm3 Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document. Exclusion Criteria Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer. Prior oxaliplatin or capecitabine use for any malignancy No prior radiation therapy to the pelvis. A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. Currently receiving any investigational agents. A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry. Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun Kim, M.D.

Phone

314-362-8502

kim.hyun@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey Olsen, M.D.

Phone

719-365-6800

First Name & Middle Initial & Last Name & Degree

Jeffrey Olsen, M.D.

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Hallemeier, M.D.

hallemeier.christopher@mayo.edu

First Name & Middle Initial & Last Name & Degree

Christopher Hallemeier, M.D.

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

Phone

314-362-8502

kim.hyun@wustl.edu

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Sean Glasgow, M.D.

First Name & Middle Initial & Last Name & Degree

Kian-Huat Lim, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Matthew Mutch, M.D.

First Name & Middle Initial & Last Name & Degree

Matthew Silviera, M.D.

First Name & Middle Initial & Last Name & Degree

Rama Suresh, M.D.

First Name & Middle Initial & Last Name & Degree

Benjamin R Tan, M.D.

First Name & Middle Initial & Last Name & Degree

Nikolaos Trikalinos, M.D.

First Name & Middle Initial & Last Name & Degree

Paul Wise, M.D.

First Name & Middle Initial & Last Name & Degree

Esther Lu, Ph.D.

First Name & Middle Initial & Last Name & Degree

David DeNardo, Ph.D.

First Name & Middle Initial & Last Name & Degree

Radhika Smith, M.D.

First Name & Middle Initial & Last Name & Degree

Lauren Henke, M.D.

First Name & Middle Initial & Last Name & Degree

Shahed Badiyan, M.D.

First Name & Middle Initial & Last Name & Degree

Pamela Samson, M.D.

First Name & Middle Initial & Last Name & Degree

Carl DeSelm, M.D.

First Name & Middle Initial & Last Name & Degree

Olivia Aranha, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Patrick Grierson, M.D., Ph.D.

Facility Name

University of Vermont Medical Center

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chris Anker, M.D.

Phone

802-847-3506

chris.anker@uvmhealth.org

First Name & Middle Initial & Last Name & Degree

Chris Anker, M.D.

First Name & Middle Initial & Last Name & Degree

Steven Ades, M.D.

First Name & Middle Initial & Last Name & Degree

Maura Berry, M.D.

First Name & Middle Initial & Last Name & Degree

Marc Greenblatt, M.D.

First Name & Middle Initial & Last Name & Degree

Nataniel Lester-Coll, M.D.

First Name & Middle Initial & Last Name & Degree

Peter Cataldo, M.D.

First Name & Middle Initial & Last Name & Degree

Jesse Moore, M.D.

First Name & Middle Initial & Last Name & Degree

Krista Evans, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified data will be shared with investigators who submit a sound proposal. Participants who opted out of data sharing in the informed consent will not be included.

IPD Sharing Time Frame

Up to 5 years after completion of the study

IPD Sharing Access Criteria

Proposals should be directed to kim.hyun@wustl.edu. To gain access, data requestors will need to sign a data access agreement and provide proof of appropriate regulatory approvals as necessary.

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Non-Operative Management and Early Response Assessment in Rectal Cancer

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