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A PHASE III STUDY OF IMMEDIATE VERSUS DELAYED CHEMOTHERAPY FOR ASYMPTOMATIC ADVANCED COLORECTAL CANCER


Phase 3
18 Years
79 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A PHASE III STUDY OF IMMEDIATE VERSUS DELAYED CHEMOTHERAPY FOR ASYMPTOMATIC ADVANCED COLORECTAL CANCER


OBJECTIVES: I. Compare survival and quality of life in asymptomatic patients with advanced
colorectal cancer randomized to immediate fluorouracil/leucovorin (5-FU/CF) vs. 5-FU/CF
delayed until onset of symptoms.

OUTLINE: Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation.
Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Arm II: Observation
followed by Single-Agent Chemotherapy with Drug Modulation. Clinical observation until
symptomatic; followed by 5-FU; with CF.

PROJECTED ACCRUAL: 144 patients will be entered over 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or
rectum that is locally advanced or metastatic Primary lesion was or is located in the
large bowel as confirmed by endoscopy, radiology, or surgery Radiologic or clinical
evidence of metastasis subsequent to resection does not require histologic or cytologic
confirmation unless: Interval between primary surgery and development of metastasis is
greater than 5 years OR Primary cancer was Dukes' A or B1 Ineligible for potentially
curative therapy, e.g.: Surgical resection of a limited hepatic or pulmonary metastasis
Irradiation of locally recurrent colon or rectal cancer No or minimal symptoms related to
the cancer, i.e.: No persistent pain requiring regular narcotic analgesia No persistent
fever greater than 38 degrees C No symptomatic bowel obstruction No persistent nausea
requiring medication No weight loss of greater than 5 kg over the previous 3 months unless
clearly not associated with the cancer (e.g., associated with surgery or intercurrent
illness) Symptomatic relapse/metastases rendered asymptomatic by secondary surgery or
radiotherapy are eligible provided the patient remains asymptomatic for at least 6 weeks
following such treatment No CNS metastases No significant ascites, pleural effusion, or
pericardial effusion

PATIENT CHARACTERISTICS: Age: Adult under 80 (i.e., of legal age to sign own informed
consent according to institutional policy) Performance status: Karnofsky 90-100% ECOG 0
Hematopoietic: Granulocytes at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than upper limit of normal Renal: Creatinine less than 2.26
mg/dL Cardiovascular: No arrhythmia Other: No infection No other medical condition that is
uncontrolled or could be aggravated by the protocol therapy No prior or concurrent second
cancer except: Nonmelanomatous skin cancer In situ cervical cancer No pregnant women
Adequate contraception required of fertile patients Blood/body fluid analyses to determine
eligibility and quality-of-life questionnaire completed within 14 days prior to
randomization; imaging studies of sites of disease completed within 28 days prior to
randomization

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for metastatic disease or local recurrence Prior fluorouracil-based or other
adjuvant therapy allowed At least 6 months required between completion of therapy and
documentation of metastasis or recurrence Endocrine therapy: Not specified Radiotherapy:
Prior radiotherapy allowed Surgery: Prior surgery allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Malcolm J. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

CO10

NCT ID:

NCT00002570

Start Date:

July 1994

Completion Date:

February 2009

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080