N/A
N=63
Non-Operative Management and Early Response Assessment in Rectal Cancer
Adenocarcinoma of the Lower Rectum
Bottom Line
View on ClinicalTrials.gov: NCT03904043 ↗Enrolled (actual)
63
Serious AEs
36.5%
Results posted
Jun 2025
Primary outcome: Primary: Clinical Complete Response Rate — 36; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation therapy (Radiation); FOLFOX regimen (Drug); CAPOX regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Complete Response Rate |
36; 2 | — |
| SECONDARY Progression-free Survival (PFS) |
— | — |
| SECONDARY Incidence of Any Grade 3 or Higher Toxicity During Treatment |
0; 1; 1; 0; 2; 0 | — |
| SECONDARY Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity |
26; 4 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being) |
25.27; 18.26; 22.97; 17.5; 23.64; 20.33 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being) |
23.87; 23.83; 24.66; 24.14; 24.65; 23.56 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being) |
18.52; 16; 19.78; 14; 19.39; 17 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being) |
21.42; 15.95; 20.91; 15.33; 20.53; 17 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale) |
22.03; 17.43; 22.03; 18; 20.82; 19.67 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score) |
89.26; 74.05; 88.24; 70.97; 88.02; 77.89 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score) |
68.68; 51.64; 66.01; 50.83; 64.91; 57 | — |
| SECONDARY Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score) |
111.32; 91.48; 110.34; 88.97; 108.84; 97.56 | — |
| SECONDARY Organ Preservation Rate |
52.83; 42.86 | — |
| SECONDARY Organ Preservation Rate |
52.83; 42.86 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03904043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.