Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

NCT03941366 | Unknown DMC

• 1 other identifier: 866142
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (4)

• Complete remission

  Percent of patients who achieve complete remission

  18 months

• Partial remission

  Percent of patients who achieve partial remission

  18 months

• Disease progression

  Percent of patients with disease progression

  18 months

• Local resection

  Percent of patients who require local resection only

  18 months

Secondary Outcomes (2)

• Patient quality of life

  18 months

• Patient health status

  18 months

Study Arms (1)

Neoadjuvant Chemotherapy and Follow-up Surgery

OTHER

All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.

Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery

Interventions

Standard of care chemotherapy with the change for avoidance of extensive surgery PROCEDURE

All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.

Neoadjuvant Chemotherapy and Follow-up Surgery

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of rectal invasive adenocarcinoma
• Tumor in the low or mid rectum (up to 11 cm from the anal verge)
• Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.
• \. Clinical staging will be estimated based on the combination of the following assessments:
• Physical examination by the primary surgeon
• Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
• Pelvic MRI and endoscopic ultrasound

You may not qualify if:

• Less than 18 years of age
• Do not complete informed consent
• Pregnant women

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Amr Aref, MD

  Ascension SME

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa C Miller, BA

CONTACT

313-343-3166; lisa.miller4@ascension.org

Susan M Szpunar, PhD

CONTACT

313-343-7838; susan.szpunar@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Radiation Oncology

Model Details: All patients in the trial receive the intervention and are followed prospectively.

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: February 26, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)