Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT05526079
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Watchfuf waiting — OTHER
    Careful review of patient response with the hope of avoiding radical surgery.

Study Details

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.

Key Dates

Start date
Jul 10, 2018
Status verified
Jan 2024
Primary completion
Jul 9, 2028
Completion
Jul 9, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Watchful Waiting
    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."

Primary Outcome Measure

Local recurrence free survival [ Time Frame: three years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascension St. John HospitalDetroitMichigan48236
Amr Aref, MD
[email protected]
313-647-3100
Karen Forman
[email protected]
313-343-4974

Find similar trials in Detroit, MI

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Ascension St. John Hospital· Detroit, MI

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