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A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer


OBJECTIVES:

Primary

- Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma
of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine,
oxaliplatin, and radiotherapy followed by local excision.

Secondary

- Determine the rate of resectability with negative resection margins in patients treated
with this regimen.

- Determine the procedure-specific morbidity and mortality in patients treated with this
regimen.

- Determine the rate of pathologic complete response of the primary tumor in patients
treated with this regimen.

- Determine the impact of this regimen on anorectal function and quality of life in these
patients.

- Determine the feasibility of using molecular studies to assess surgical resection
margins and tumor response in patients treated with this regimen.

- Determine molecular markers associated with local tumor recurrence in patients treated
with this regimen.

OUTLINE: This is a non-randomized, multicenter study.

Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19,
22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35
and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after
completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with
T3 disease or positive resection margins after local excision undergo radical resection of
the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the
physician.

Quality of life is assessed at baseline and then 1 year after surgery.

After completion of study treatment, patients are followed at 1 month, every 4 months for 3
years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive adenocarcinoma of the rectum

- T2, N0 (stage I) disease by endorectal ultrasound (ERUS) scan

- No T1, T3, or T4 disease

- No tumors fixed to adjacent structures by digital exam

- Greatest tumor diameter ≤ 4 cm

- Distal border of the tumor must be ≤ 8 cm from the anal verge by rigid
proctoscopic exam

- No positive perirectal nodes by ERUS scan

- No histologic evidence of metastatic invasion of inguinal lymph nodes

- No metastatic or other primary disease by chest x-ray/CT scan, abdominal and pelvic
CT scan/MRI with contrast, and colonoscopy

- No documented history of familial adenomatous polyposis

- No documented history of hereditary non-polyposis colorectal cancer diagnosed
clinically or by genetic testing

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Hemoglobin > 9.5 mg/dL

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST and ALT ≤ 2.0 times upper limit of normal (ULN)

- Bilirubin ≤ 3 mg/dL

- Alkaline phosphatase ≤ 2.0 times ULN

Renal

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- No history of New York Heart Association class III-IV congestive heart failure

- No history of symptomatic coronary artery disease

- No history of uncontrolled arrhythmia

- No myocardial infarction within the past 6 months

- No history of any other clinically significant cardiac disease

Gastrointestinal

- No history of inflammatory bowel disease

- No history of difficulty or inability to take or absorb oral medications

Neurologic

- No clinically significant peripheral sensory or motor neuropathy

- No history of uncontrolled seizures or clinically significant central nervous system
disorder

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergy and/or hypersensitivity to capecitabine or oxaliplatin

- No other malignancy within the past 5 years except curatively treated nonmelanoma
skin carcinoma or in situ carcinoma

- No history of psychiatric conditions or diminished mental capacity that would
preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to the pelvis

- No concurrent intensity modulated radiotherapy

Surgery

- Not specified

Other

- No other concurrent investigational drugs

- No other concurrent anticancer treatment

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years

Safety Issue:

No

Principal Investigator

Julio Garcia-Aguilar, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000433145

NCT ID:

NCT00114231

Start Date:

May 2006

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence Cancer Center at Holy Family HospitalSpokane, Washington  99207
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Praxair Cancer Center at Danbury HospitalDanbury, Connecticut  06810
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
Methodist HospitalHouston, Texas  77030
St. Vincent's Medical CenterBridgeport, Connecticut  06606
UPMC Cancer Center at UPMC PresbyterianPittsburgh, Pennsylvania  15213
Tampa General HospitalTampa, Florida  33606
Integris Oncology ServicesOklahoma City, Oklahoma  73112
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
UPMC Cancer Center at Beaver Medical CenterBeaver, Pennsylvania  15009
UPMC Cancer Center at Jefferson Regional Medical CenterClairton, Pennsylvania  15025
UPMC Cancer Center - Arnold Palmer PavilionGreensburg, Pennsylvania  15601
UPMC Cancer Center at the John P. Murtha PavilionJohnstown, Pennsylvania  15901
UPMC - MoonMoon Township, Pennsylvania  15108
UPMC Cancer Center - Natrona HeightsNatrona Heights, Pennsylvania  15065
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
UPMC - ShadysidePittsburgh, Pennsylvania  15213-2582
UPMC Cancer Center at UPMC St. MargaretPittsburgh, Pennsylvania  15215
St. Clair Memorial Hospital Cancer CenterPittsburgh, Pennsylvania  15243
UPMC Cancer Center at UPMC PassavantPittsburgh, Pennsylvania  15237
UPMC Cancer Center at UPMC NorthwestSeneca, Pennsylvania  16346
Washington Hospital Cancer CenterWashington, Pennsylvania  15301
United Hospital CenterClarksburg, West Virginia  26301
Surgical Oncology AssociatesNewport News, Virginia  23606