Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

NCT05526079 | Recruiting Phase 2 DMC

• 1 other identifier: 1291129
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine if in a selected group of patients, at higher risk of wound dehiscence and other complications, treatment by local excision and management by a "watchful waiting" or an initial "non-operative management" approach, with an offer of radical resection only to those patients whose tumors demonstrate "regrowth" will maintain acceptable local control and overall survival rate for the whole cohort.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Local recurrence free survival

  Survival without recurrence of the cancer

  three years

Secondary Outcomes (1)

• Quality of life using LARS score

  three years

Study Arms (1)

Watchful Waiting

EXPERIMENTAL

Six cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) will be administered every two weeks according to protocol. After a 3 week recovery period, this will be followed by conventional concurrent radiation and 5FU/capecitabine. Patients will be re-staged two to three weeks after completion of induction FOLFOX therapy to ensure no disease progression. The patients will be re-staged again at least 7-11 weeks post completion of nCRT. Patients with restaging results showing either complete or near complete response, will be allocated to "watchful waiting."

Other: Watchfuf waiting

Interventions

Watchfuf waiting OTHER

Careful review of patient response with the hope of avoiding radical surgery.

Watchful Waiting

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 rectum lying \< 4 cm from the anal verge
• Clinical stage T3/N0-N1M0.
• Patients with low T2 who will need abdominal perineal resection are also eligible.

You may not qualify if:

• Age less than 18 years
• Other forms of cancer
• Tumors \>= 4 cm from the anal verge
• Tumors of other clinical stages than listed above

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 St. John Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Aref, MD

CONTACT

(313) 647-3100; amr.aref@ascension.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Radiation

Model Details: Induction FOLFOX Chemotherapy followed by concurrent chemoradiotherapy and nonoperative surveillance for complete responders

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: September 2, 2022
• Study Start: July 10, 2018
• Primary Completion (Estimated): July 9, 2028
• Study Completion (Estimated): July 9, 2029
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)