Adenocarcinoma of the Lower Rectum Clinical Trial
— NOM-ERAOfficial title:
Non-Operative Management and Early Response Assessment in Rectal Cancer
| Verified date | April 2024 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 63 |
| Est. completion date | April 30, 2026 |
| Est. primary completion date | September 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado | Aurora | Colorado |
| United States | University of Vermont Medical Center | Burlington | Vermont |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) |
Completion of treatment (estimated to be 22 weeks) | |
| Secondary | Progression-free survival (PFS) | Criteria for progressive disease:
Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm) New metastatic disease PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up. |
2 years | |
| Secondary | 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. | Completion of treatment (estimated to be 22 weeks) | |
| Secondary | 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. | 1 year | |
| Secondary | 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 |
1 year (between 10-14 months post treatment start date) | |
| Secondary | Organ preservation rate | 1 year | ||
| Secondary | Organ preservation rate | 2 years |