Clinical trial NCT03904043: Non-Operative Management and Early Response Assessment in Rectal Cancer
Official title: Non-Operative Management and Early Response Assessment in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adenocarcinoma of the Lower Rectum
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical Complete Response Rate
timeFrame: Completion of treatment (estimated to be 22 weeks)
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: At 2 years
measure: Incidence of Any Grade 3 or Higher Toxicity During Treatment
timeFrame: From start of treatment through the completion of treatment (estimated to be 22 weeks)
measure: Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity
timeFrame: At 1 year after the start of radiation
measure: Quality of Anorectal Function as Measured by the FACT-C Questionnaire
timeFrame: 10-14 months after radiation therapy
measure: Organ Preservation Rate
timeFrame: At 1 year
measure: Organ Preservation Rate
timeFrame: At 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Washington University School of Medicine
name: Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: