Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

NCT ID: NCT00831181

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2009-11-30

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.

Detailed Description

OBJECTIVES:

Primary

• To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy.

Secondary

• To observe the overall pathologic response rate in these patients.
• To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
• To assess toxic side effects of these regimens in these patients.
• To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients.

OUTLINE:

Patients with stage II/III rectal cancer were treated with OXA 60mg/m2 weekly continuous infusion 5FU of 225 mg/m2/d d1-5 with pelvic RT of 1.8Gy/d for 28 doses. Adjuvant therapy consisted of 6 cycles of biweekly FOLFOX6.

Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.

Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative Chemoradiation

Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)

Group Type: EXPERIMENTAL

5-FU

Intervention Type: DRUG

5-FU: continuous infusion via portable pump during all RT (approximately 33 days)

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)

leucovorin

Intervention Type: DRUG

Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin

mesorectal excision

Intervention Type: PROCEDURE

mesorectal excision

Interventions

5-FU

5-FU: continuous infusion via portable pump during all RT (approximately 33 days)

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)

Intervention Type: DRUG

leucovorin

Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin

Intervention Type: DRUG

mesorectal excision

mesorectal excision

Intervention Type: PROCEDURE

Other Intervention Names

fluorouracil; Eloxatin; Folinic Acid

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kozuch, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Locations

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, United States

St. Luke's-Roosevelt Hospital Center - Roosevelt Division

New York, New York, United States

Countries

United States

Other Identifiers

BIMCP-OX-08-006

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVENTIS-BIMCP-OX-08-006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000633360

Identifier Type: -

Identifier Source: org_study_id