Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
A Phase II Open-labeled, Prospective Study to Determine the Efficacy of Preoperative Chemoradiation With Oxaliplatin/5-FU in Locally Advanced Rectal Cancer Followed by Total Mesorectal Excision and FOLFOX6
3 other identifiers
interventional
27
1 country
2
Brief Summary
RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer. Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 colorectal-cancer
Started Jul 2004
Longer than P75 for phase_2 colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
March 20, 2018
CompletedMarch 20, 2018
February 1, 2018
5.3 years
January 27, 2009
January 9, 2013
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic Response and Complete Response
Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation. The unit of measure is the tumor response rate to preoperative chemoradiation. Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer. Tumor regression grade (TRG) will be quantitated into five grades: TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall. TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis. TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant. TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months
Secondary Outcomes (7)
Treatment Toxicity
Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).
Complete Resectability Rates
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Local Regional Control
median follow-up 22 months post-TME
Disease-free Survival
median 22 months follow-up
Overall Survival
median follow-up 22 months
- +2 more secondary outcomes
Study Arms (1)
Preoperative Chemoradiation
EXPERIMENTALPreoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)
Interventions
5-FU: continuous infusion via portable pump during all RT (approximately 33 days)
Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)
Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin
Eligibility Criteria
You may qualify if:
- Histologically proven adenocarcinoma of the rectum with no distant metastases.
- T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT
- The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.
- No prior chemotherapy or pelvic irradiation.
- ECOG performance status 0-1
- Age 18 to 70 years
- ANC \>= 1500/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:
- Pregnant or lactating females; patients not practicing active contraception while sexually active.
- No other serious medical condition
- A psychiatric disorder that would prohibit the subject from participating fully.
- Peripheral neuropathy \> grade 1
- History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.
- HIV positive patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, 10003, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, 10019, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Peter Kozuch
- Organization
- Beth Israel Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kozuch, MD
Beth Israel Medical Center
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 28, 2009
Study Start
July 1, 2004
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
March 20, 2018
Results First Posted
March 20, 2018
Record last verified: 2018-02