Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer

NCT03781323 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: UGIC18095
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.

Conditions

Advanced Rectal Cancer

Keywords

Advanced rectal cancer; FOLFOX (fluorouracil, leucovorin, oxaliplatin)

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a Complete Clinical Response.

  * A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations. * A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring. * Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decrease in size without obtaining near or complete response. * Stable disease, in our study, will be those tumors read with RECIST criteria with a \<20% decrease in size without obtaining near or complete response. * Progressive disease will be those tumors with \>20% increase in size by RECIST version 1.1 criteria on imaging.

  1 year

Secondary Outcomes (4)

• Proportion of Patients With Survival

  5 years

• Proportion of Patients With Survival

  5 years

• Proportion of Patients With Survival

  5 years

• Proportion of Patients With Survival

  5 years

Study Arms (1)

mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)

EXPERIMENTAL

Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.

Drug: FOLFOX

Interventions

FOLFOX DRUG

Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.

mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)

Eligibility Criteria

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

You may qualify if:

• Participants must be \>18 years old at time of diagnosis
• Histologically confirmed adenocarcinoma of the rectum from biopsy, defined as adenocarcinoma \<15 cm from the anal verge
• Clinical staging including T3N0 tumors, or T1-3 with N1-2a disease
• Patients with lower rectal cancer deemed by surgery to not be candidates for sphincter sparing surgery are eligible to participate
• There must be no evidence of metastatic disease any time prior to initiation of study
• Rectal tumors must be determined as likely requiring total mesorectal excision (TME)
• Participant must be treatment naïve for rectal cancer, with no prior radiation chemotherapy, radiation, or surgery for specific rectal cancer
• No history of prior pelvic radiation
• No prior administration of platinum agents
• No active infections requiring intravenous antibiotics
• No additional active malignancy
• No prior treatment of any malignancy within the past 3 years
• Baseline lab work must meet the following parameters:
• Absolute neutrophil count (ANC)\>1500/mm3
• Platelet count\>100,000/mm3

You may not qualify if:

• Recurrent or refractory rectal adenocarcinoma
• T1N0, T2N0, T4a, T4b, or N2b tumors
• Any evidence of metastatic disease
• Primary unresectable rectal cancer. A tumor will be considered unresectable when invading adjacent organs such that an en bloc resection cannot achieve negative margins
• Patients with threatened margins, defined as tumor \<1 mm from circumferential resection margins or mesorectal fascia
• Patients unable to undergo MRI imaging
• Patient with a history of any arterial thrombotic event within the past 6 months. This includes angina, myocardial infarction, transient ischemic attack, or cerebral vascular accident.
• Patients with history of venous thrombotic episodes such as deep vein thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Patients who are anticoagulated for atrial fibrillation or other conditions may participate only if on stable doses of anticoagulant therapy.
• Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy
• Peripheral neuropathy\>grade 1 by Common Terminology Criteria for Adverse Events, or CTCAEa
• The patient must not be on any clinical trials involving other experimental therapies before or during study treatment
• Women who are currently pregnant or breast-feeding
• Men and women expecting to father/conceive children
• Patients with any other concord medical or psychiatric condition which were deemed inappropriate for entry into the study per the investigator.
• History of other invasive malignancy within the past 3 years, except for adequately treated non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ or carcinoma in situ of the cervix.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

University of Rochester, James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Folfox protocol

Results Point of Contact

• Title: Richard Dunne
• Organization: University of Rochester

Richard_Dunne@urmc.rochester.edu

585-275-5823

Study Officials

• Richard Dunne

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Associate Professor of Hematology/Oncology

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: May 3, 2019
• Primary Completion: June 1, 2022
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 13, 2024
• Results First Posted: September 11, 2023

Record last verified: 2024-12

Locations

US (2)