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Colorectal CancerPhase 3NCT00002570

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

A Phase 3 study testing fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by NCIC Clinical Trials Group at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil and leucovorin calcium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
16 sitesUnited States
Study dates
15 Jul 1994to 10 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota, 58501

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CentraCare Clinic

    Saint Cloud, Minnesota, 56303

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer

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.

Read the 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.

Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluorouracilDrug

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

  • leucovorin calciumDrug

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

Study groups in NCT00002570
Study groupRoleWhat they receive
Fluorouracil and folinic acidActive comparatorNot described
Receives: Drug: fluorouracil; Drug: leucovorin calcium
ObservationNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Measured: 8 years

Secondary outcomes (5)

  1. Quality of life

    Measured: 8 years

  2. Toxicity

    Measured: 8 years

  3. Time to progression

    Measured: 8 years

  4. response rate

    Measured: 8 years

  5. response duration

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2004 (estimated)
  2. Study start15 Jul 1994
  3. Primary completionNov 2000
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002570
Sponsor's protocol ID
CO10
Other IDs
CAN-NCIC-CO10, NCCTG-JCO10, NCI-V94-0463, CDR0000063607
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 16265352

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by NCIC Clinical Trials Group at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002570, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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