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Timing of Rectal Cancer Response to Chemoradiation


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

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Trial Information

Timing of Rectal Cancer Response to Chemoradiation


OBJECTIVES:

I. To determine the rate of pathologic complete response to chemoradiation (no evidence of
residual tumor in the resected specimen) of Stage II and Stage III rectal cancers that are
staged preoperatively by endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI),
treated according to a standardized chemoradiation and surgery protocol, and evaluated by a
systematic pathologic exam of the surgical specimen.

II. To study the effect of different chemoradiation-to-surgery intervals on the rate of
pathologic complete response, on surgical difficulty, and on postoperative complications.

III. To investigate the feasibility of using sensitive molecular assays to detect tumor
cells in the tumor bed and regional lymph nodes of rectal cancer specimens, with or without
pathologic complete response to preoperative chemoradiation.

OUTLINE:

Patients are assigned to 1 of 4 treatment groups. All patients undergo chemoradiation
therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil
intravenously (IV) continuously over 24 hours 7 days a week for 6 weeks.

GROUP I (closed to enrollment): Patients undergo standard surgical resection after
completion of chemoradiation therapy.

GROUP II (closed to enrollment): Beginning 4 weeks after completion of chemoradiation
therapy, patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2
hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over
46 hours on days 1-2. Treatment repeats every 14 days for 2 courses. After the last week of
post-radiation chemotherapy, patients undergo standard surgical resection.

GROUP III: Beginning 4 weeks after completion of chemoradiation therapy, patients receive
modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 4
courses. After the last week of post-radiation chemotherapy, patients undergo standard
surgical resection.

GROUP IV: Beginning 4 weeks after completion of chemoradiation therapy, patients receive
modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 6
courses. After the last week of post- radiation chemotherapy, patients undergo standard
surgical resection.

In all groups, treatment continues in the absence of disease progression or unacceptable
toxicity. A

fter completion of study treatment, patients are followed up for 5 years.


Inclusion Criteria:



- Patients must have an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1, or
comparable Karnofsky performance status

- Patients must have histologically confirmed invasive adenocarcinoma of the rectum
Distal border of the tumor must be within 12 cm from the anal verge as measured on
rigid proctoscopic exam

- Patients must have Stage II (uT3-4, uN0) or Stage III (any T, uN1-2) tumors, as
confirmed by ERUS or MRI; females with anterior tumors invading the posterior vaginal
wall (uT4) and males with anterior tumors that invade the seminal vesicles or
adjacent organs (uT4) will also be eligible provided they undergo an extended
resection including the organs involved

- Patients with high grade obstruction that impedes the ERUS exam are eligible for the
study provided they can be staged by MRI

- Patients with synchronous or metachronous colorectal cancer are eligible for the
study on condition that they are treated for rectal cancer in accordance with the
protocol

- Patients with the following are NOT allowed on study:

- Metastatic disease or other primaries

- Locally recurrent rectal cancer

- Previously documented history of Familial Adenomatous Polyposis

- History of Inflammatory Bowel Disease

- History of prior radiation treatments to pelvis

- History of clinically significant cardiac disease (i.e., Class 3-4 congestive
heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia,
and/or myocardial infarction within the previous 6 months

- History of uncontrolled seizures or clinically significant central nervous
system disorders

- History of psychiatric conditions or diminished capacity that could compromise
the giving of informed consent, or interfere with study compliance

- History of allergy and/or hypersensitivity to 5-fluorouracil (fluorouracil),
leucovorin (leucovorin calcium), and/or oxaliplatin

- History of difficulty or inability to take or absorb oral medications

- Patients must have adequate bone marrow, hepatic and renal function within 7 days
prior to registration

- White blood cells (WBC) >= 3,000 mm^3

- Absolute neutrophil count (ANC) > 1,500 mm^3

- Hemoglobin > 9.5 mg/dl

- Platelet count >= 100,000 mm^3

- Total bilirubin =< 1.5 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
2.0 times institutional upper limit of normal (ULN)

- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.0
times ULN

- Alkaline phosphatase =< 2.0 times ULN

- Serum creatinine =< 1.5 times ULN

- Patients with hereditary non-polyposis colorectal cancer are eligible for the study
provided they meet the rest of the eligibility criteria

- Patients who have experienced a prior malignancy should have received potentially
curative therapy for that malignancy, and should be cancer-free for at least five
years from the date of initial diagnosis (Exceptions: patients treated for basal cell
carcinoma, or carcinoma in-situ of the cervix)

- Patients of reproductive potential should agree to use an effective method of birth
control when undergoing treatments with known or possible mutagenic or teratogenic
effects; all female participants of childbearing potential must have a negative urine
or serum pregnancy test within two weeks prior to study registration

- Patients or the patient's legally acceptable representative must provide written
authorization to allow the use and disclosure of protected health information; NOTE:
this may be obtained in either the study-specific informed consent or in a separate
authorization form and must be obtained from the patient prior to study registration
or the initiation of any study-specific procedures

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathologic complete response

Outcome Time Frame:

Determined at the time of surgery

Safety Issue:

No

Principal Investigator

Julio Garcia-Aguilar, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

mskcc 12-201

NCT ID:

NCT00335816

Start Date:

August 2008

Completion Date:

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
City of Hope Medical CenterDuarte, California  91010
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Colon and Rectal Surgery, IncorporatedOmaha, Nebraska  68114