Clinical trial NCT02641691: Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum
Official title: Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of Rectum
Cancer of the Rectum
Neoplasm, Rectum
Rectal Cancer
Rectum Cancer
Rectum Neoplasms
Adenocarcinoma of the Rectum
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound
* Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a
* ECOG performance status 0-2
* At least 18 years of age
* Adequate bone marrow function defined as:

  * ANC \> 1,500 cells/mm3
  * Hgb \> 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 IRB-approved written informed consent document.

Exclusion Criteria:

* No clinically detectable (MR, endoscopy or DRE) tumor present
* Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
* Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible.
* Currently receiving any investigational agents.
* A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
* Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Primary outcomes:
measure: Complete Response Rate
timeFrame: 1 year
Secondary outcomes:
measure: Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
timeFrame: Baseline
measure: Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
timeFrame: Completion of chemoradiation (approximately 112 days)
measure: Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
timeFrame: 10-14 months after chemoradiation (approximately 16-20 months)
measure: Number of Any Grade 3 or Higher Toxicities
timeFrame: From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)
measure: Number of Post Chemotherapy Grade 3 or Higher Toxicities
timeFrame: Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)
measure: Quality of Anorectal Function as Measured by the FACT-C Questionnaire
timeFrame: Baseline
measure: Quality of Anorectal Function as Measured by the FACT-C Questionnaire
timeFrame: Completion of chemoradiation (approximately 112 days)
measure: Quality of Anorectal Function as Measured by the FACT-C Questionnaire
timeFrame: 10-14 months after chemoradiation (approximately 16-20 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim H, Pedersen K, Olsen JR, Mutch MG, Chin RI, Glasgow SC, Wise PE, Silviera ML, Tan BR, Wang-Gillam A, Lim KH, Suresh R, Amin M, Huang Y, Henke LE, Park H, Ciorba MA, Badiyan S, Parikh PJ, Roach MC, Hunt SR. Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial. Clin Colorectal Cancer. 2021 Sep;20(3):e185-e193. doi: 10.1016/j.clcc.2021.03.003. Epub 2021 Apr 7.