Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

Rectal Cancer Clinical Trial

— NORMAL-R  

Official title:

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641691
• Other study ID #: 201512140
• Status: Completed
• Phase: Phase 2
• Start date: May 27, 2016
• Est. completion date: March 29, 2020

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 29, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Rectum
• Cancer of Rectum
• Cancer of the Rectum
• Neoplasm, Rectum
• Neoplasms
• Rectal Cancer
• Rectal Neoplasms
• Rectum Cancer
• Rectum Neoplasms

Intervention

Radiation:
• Radiation

Drug:
• Oxaliplatin

• Leucovorin

• Fluorouracil

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	Criteria for complete clinical response: No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer; No radiographic evidence of tumor on DRE; Substantial downsizing 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); Criteria for no significant clinical response: Residual disease by DRE, endoscopy or MR.; Increase in primary tumor size upon clinical exam or imaging; Any new lesions	1 year
Secondary	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).	Baseline
Secondary	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).	Completion of chemoradiation (approximately 112 days)
Secondary	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).	10-14 months after chemoradiation (approximately 16-20 months)
Secondary	Number of Any Grade 3 or Higher Toxicities	-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.	From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)
Secondary	Number of Post Chemotherapy Grade 3 or Higher Toxicities	-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.	Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)
Secondary	Quality of Anorectal Function as Measured by the FACT-C Questionnaire	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)	Baseline
Secondary	Quality of Anorectal Function as Measured by the FACT-C Questionnaire	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)	Completion of chemoradiation (approximately 112 days)
Secondary	Quality of Anorectal Function as Measured by the FACT-C Questionnaire	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)	10-14 months after chemoradiation (approximately 16-20 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine