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Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Last Updated: 2018-09-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2016-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289).

Secondary

* To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer.
* To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.
* To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy.
* To estimate the time to treatment failure and patterns of failure.
* To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.
* To evaluate the rate of abdominoperineal resections.

OUTLINE: This is a multicenter study.

* Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.
* Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor.
* Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT + Chemotherapy , Resection, Postoperative Chemotherapy

Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Group Type OTHER

capecitabine

Intervention Type DRUG

1650 mg/m\^2/day orally 5 days/week during radiotherapy.

oxaliplatin

Intervention Type DRUG

resection

Intervention Type PROCEDURE

All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.

radiation therapy

Intervention Type RADIATION

Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx

FOLFOX

Intervention Type DRUG

Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m\^2, IV over 2 hours, day 1.

Leucovorin 400 mg/m\^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m\^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m\^2, IV continuous infusion over 46 hours, day 1.

Interventions

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capecitabine

1650 mg/m\^2/day orally 5 days/week during radiotherapy.

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

resection

Intervention Type PROCEDURE

radiation therapy

Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx

Intervention Type RADIATION

FOLFOX

Intervention Type DRUG

Other Intervention Names

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50 mg/m^2 IV over 2 hours weekly for five weeks starting on day 1 of radiotherapy. Oxaliplatin, leucovorin, 5-fluorouracil

Eligibility Criteria

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Inclusion Criteria

* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,800/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
* Aspartate aminotransferase (AST) \< 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 times ULN
* Bilirubin ≤ 1.5 times ULN
* Creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years

Exclusion Criteria

* Severe, active comorbidity, defined as follows:

* Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* AIDS
* Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
* Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
* Evidence of peripheral neuropathy ≥ grade 2
* Prior allergic reaction to oxaliplatin or capecitabine
* Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
* Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
* Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
* Participation in any investigational drug study within 28 days of study enrollment.
* Concurrent cimetidine, amifostine, and/or depot Sandostatin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael C. Garofalo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Adam C. Berger, MD

Role: STUDY_CHAIR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Johanna Bendell, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

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Providence Cancer Center at Providence Hospital

Mobile, Alabama, United States

Site Status

Auburn Radiation Oncology

Auburn, California, United States

Site Status

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Site Status

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

California Cancer Center - Woodward Park Office

Fresno, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Radiation Oncology Center - Roseville

Roseville, California, United States

Site Status

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

Veterans Affairs Medical Center - San Diego

San Diego, California, United States

Site Status

Solano Radiation Oncology Center

Vacaville, California, United States

Site Status

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

Boca Raton, Florida, United States

Site Status

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

Site Status

Integrated Community Oncology Network - Orange Park

Orange Park, Florida, United States

Site Status

Bay Medical

Panama City, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Site Status

Saint John's Cancer Center at Saint John's Medical Center

Anderson, Indiana, United States

Site Status

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, United States

Site Status

St. Vincent Oncology Center

Indianapolis, Indiana, United States

Site Status

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Boston University Cancer Research Center

Boston, Massachusetts, United States

Site Status

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, United States

Site Status

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, United States

Site Status

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Site Status

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, United States

Site Status