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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    68
  • sponsor
    Washington University School of Medicine
Updated on 7 October 2022

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.

Details
Condition Adenocarcinoma of the Lower Rectum
Treatment radiation therapy, FOLFOX regimen, Blood for ctDNA, Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire, Rectal biopsy samples
Clinical Study IdentifierNCT03904043
SponsorWashington University School of Medicine
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document
(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

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
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
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
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
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