Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease

NCT ID: NCT00002570

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-07-15
• Study Completion Date: 2009-02-10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease.

Detailed Description

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluorouracil and folinic acid

Group Type: ACTIVE_COMPARATOR

fluorouracil

Intervention Type: DRUG

425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days

leucovorin calcium

Intervention Type: DRUG

20 mg/m2 IV - number of cycles is determined by patient and physician

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fluorouracil

425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days

Intervention Type: DRUG

leucovorin calcium

20 mg/m2 IV - number of cycles is determined by patient and physician

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Central Cancer Treatment Group

NETWORK

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm J. Moore, MD

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Henry C. Pitot, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

CCOP - Duluth

Duluth, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CentraCare Clinic

Saint Cloud, Minnesota, United States

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Altru Health Systems

Grand Forks, North Dakota, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Countries

United States

References

Hummer A, Carlo W, Sullivan D, et al.: Extensive hepatic resection does not correlate with toxicity following adjuvant chemotherapy. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-526, 2002.

Reference Type: RESULT

Ackland SP, Jones M, Tu D, Simes J, Yuen J, Sargeant AM, Dhillon H, Goldberg RM, Abdi E, Shepherd L, Moore MJ. A meta-analysis of two randomised trials of early chemotherapy in asymptomatic metastatic colorectal cancer. Br J Cancer. 2005 Nov 28;93(11):1236-43. doi: 10.1038/sj.bjc.6602841.

Reference Type: RESULT

PMID: 16265352 (View on PubMed)

Other Identifiers

CAN-NCIC-CO10

Identifier Type: OTHER

Identifier Source: secondary_id

NCCTG-JCO10

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-V94-0463

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000063607

Identifier Type: OTHER

Identifier Source: secondary_id

CO10

Identifier Type: -

Identifier Source: org_study_id