NCT00832299

Brief Summary

A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objectives of this study are the following:

  1. 1.The primary endpoint of this trial is pathologic complete response (response rate).
  2. 2.Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 22, 2013

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

January 27, 2009

Results QC Date

February 25, 2013

Last Update Submit

February 1, 2018

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response

    3-6 months

Secondary Outcomes (1)

  • Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival

    5 years

Study Arms (1)

6 cycles of FOLFOX pre and post TME

EXPERIMENTAL
Drug: FOLFOXProcedure: total mesorectal excision (TME)

Interventions

FOLFOXDRUG

6 cycles of neo-adjuvant mFOLFOX6

Also known as: oxaliplatin, leucovorin, 5-fluorouracil
6 cycles of FOLFOX pre and post TME
total mesorectal excision (TME)PROCEDURE

TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.

Also known as: Total Mesorectal Excision
6 cycles of FOLFOX pre and post TME

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must consent to participate in the study and must have signed and dated an IRB-approved consent form conforming to federal and institutional guidelines
  • Patient must have histologically proven adenocarcinoma of the rectum with no distant metastases
  • Tumor stage must be T3N0M0, T1-3 N1M0 assessed by clinical exam, TRUS, MRI and CT. Pre-operative evidence of T4, N2 or distal lesions (0-6 cm from anal verge) should receive preoperative RT and not be offered this protocol. Any pT4, pN2 or CRM+ patients should be offered postoperative radiation
  • The proximal border of the tumor must be at or below 12 centimeters of the anal verge by proctoscopic examination
  • The distal border of the tumor must be at or above 6 cm from the anal verge on preoperative proctoscopy with the patient in the left lateral decubitus position
  • Patient must have had no prior chemotherapy or pelvic irradiation
  • Karnofsky performance status of 60 or greater; ECOG performance status 0-1
  • Patients should be age 18 years and older
  • Pretreatment absolute neutrophil count \>= 1000/mm3 and platelets \>= 100,000/mm3
  • Serum creatinine \<= 1.5 x ULN; bilirubin \<= 1.5 x ULN; ALT\<= 2.5 x ULN

You may not qualify if:

  • Patients can not be receiving any other investigational agents
  • Patients with known metastases will be excluded from the study
  • Patients with history of significant neuropathy or current symptoms of neuropathy
  • Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin or 5-FU or leucovorin
  • Patients with uncontrolled intercurrent illness 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 women are excluded from this study because oxaliplatin and 5-FU/LV are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin and 5-FU/LV, breastfeeding should be discontinued if the mother is treated with these agents
  • HIV positive patients
  • Patients with serious comorbid disease which prevents delivery of full treatment including psychiatric disorders and cardiopulmonary disease
  • No history within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma
  • Patients with clinically significant peripheral neuropathy at the time of start of treatment (defined in the NCI Common Terminology Criteria for Adverse Events Version 3\[CTCAE v3.0\] as grade 2 or greater neurosensory or neuromotor toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Folfox protocolOxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Peter Kozuch, MD
Organization
Beth Israel Medical Center
pkozuch@chpnet.org

Study Officials

  • Peter Kozuch, MD

    Beth Israel Medical Center

    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
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 30, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 1, 2018

Results First Posted

April 22, 2013

Record last verified: 2018-02

Locations

US(2)