Know Cancer

forgot password

A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer



- 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).


- 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

- 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.

Inclusion Criteria


- Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy
technique that does not completely excise the lesion (e.g., fine needle aspiration,
core needle biopsy)

- Located up to 12 cm from the anal verge with no extension of malignant disease
into the anal canal

- Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by
the following assessments:

- Colonoscopy and biopsy within 56 days prior to registration

- History/physical examination (including medication history screen for
contraindications) within 56 days prior to registration

- Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or
PET-CT (whole body preferred) within 56 days prior to registration

- Chest x-ray (or CT) of the chest within within 56 days prior to
registration to exclude distant metastases (except for patients who have
had whole body PET-CT)

- Transrectal ultrasound (TRUS) within 56 days prior to registration required
to establish tumor stage

- TRUS not required if clinical exam, CT of the pelvis, and/or MRI
demonstrates T4 lesion

- No synchronous primary colon carcinoma

- No evidence of distant metastases (M1)


Inclusion criteria:

- Zubrod performance status 0-2

- ANC (absolute neutrophil count) ≥ 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)

- AST (aspartate aminotransferase) < 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively

Outcome Description:

The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.

Outcome Time Frame:

From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Safety Issue:


Principal Investigator

Michael C. Garofalo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms



CCOP - Kansas City Kansas City, Missouri  64131
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
LDS Hospital Salt Lake City, Utah  84143
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
City of Hope Comprehensive Cancer Center Duarte, California  91010
Veterans Affairs Medical Center - San Diego San Diego, California  92161
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
Long Island Jewish Medical Center New Hyde Park, New York  11040
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Maimonides Cancer Center at Maimonides Medical Center Brooklyn, New York  11219
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
University of Virginia Cancer Center Charlottesville, Virginia  22908
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Piedmont Hospital Atlanta, Georgia  30309
Kingsbury Center for Cancer Care at Cheshire Medical Center Keene, New Hampshire  03431
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Massachusetts General Hospital Boston, Massachusetts  02114-2617
California Cancer Center - Woodward Park Office Fresno, California  93720
Cancer Center at Ball Memorial Hospital Muncie, Indiana  47303
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Cancer Treatment Center Wooster, Ohio  44691
John B. Amos Cancer Center Columbus, Georgia  31904
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Solano Radiation Oncology Center Vacaville, California  95687
Boston University Cancer Research Center Boston, Massachusetts  02118
Parvin Radiation Oncology Kansas City, Missouri  64116
Mercy General Hospital Sacramento, California  95819
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
Riddle Memorial Hospital Cancer Center Media, Pennsylvania  19063
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
Cancer Care Center, Incorporated Salem, Ohio  44460
Center for Cancer Care at Goshen General Hospital Goshen, Indiana  46526
Bay Medical Panama City, Florida  32401
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Precision Radiotherapy at University Pointe West Chester, Ohio  45069
Integrated Community Oncology Network - Orange Park Orange Park, Florida  32073
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Frankford Hospital Cancer Center - Torresdale Campus Philadelphia, Pennsylvania  19114
Integris Oncology Services Oklahoma City, Oklahoma  73112
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus Boca Raton, Florida  33486
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Saint John's Cancer Center at Saint John's Medical Center Anderson, Indiana  46016
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
Barnes-Jewish West County Hospital Saint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Saint Peters, Missouri  63376
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Norris Cotton Cancer Center - North Saint Johnsbury, Vermont  05819
Northeast Radiation Oncology Center Dunmore, Pennsylvania  18512
Nebraska Medical Center Omaha, Nebraska  68198
Upper Delaware Valley Cancer Center Milford, Pennsylvania  18337
St. Vincent Oncology Center Indianapolis, Indiana  46260