Colorectal CancerPhase 3NCT00003063
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
A Phase 3 study testing recombinant interferon alfa, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by European Institute of Oncology at 85 sites in 3 countries.
Trial summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- recombinant interferon alfa, fluorouracil and leucovorin calcium
- How many people
- 1,050 participants
- Where
- 85 sitesin 3 countries
- Study dates
- Nov 1991to not given
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer
- No evidence of residual disease after surgery
- Tumor located above peritoneal reflection
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGPT less than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No serious cardiac ischemia
Other:
- Adequate metabolic functions
- No prior neoplasm
- No prior/concurrent illness
- No insulin-dependent diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy for the current cancer
Chemotherapy
- No prior chemotherapy for the current cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for the current cancer
Surgery
- Not specified
Trial locations and contacts
85 sites in 3 countries.
85 sites in 3 countries
Italy83 sites
Ospedale Bassini
Balsamo Cinisello, 20092
Universita Degli Studi di Bari Policlinico
Bari, 70124
Spedali Civili
Brescia, 25124
Cattedra di Oncologia Medica - Universita
Cagliari, 09124
Ospedale Oncologico A. Businco
Cagliari, 09124
Ospedale San Michele
Cagliari, 9100
Ospedale Sant Anna
Como, 22100
Ospedale Valduce
Como, 22100
Ospedale Di Conselice
Conselice, 48017
Ospedale Civile Cosenza
Cosenza, 87100
Ospedale Maggiore Crema
Crema, 26013
Ospedale Santa Croce
Cuneo, 12100
Ospedale Civile Feltre
Feltre, 32100
Universita di Ferrara
Ferrara, 44100
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), 1 (50134)
Policlinico di Careggi
Firenze (Florence), 50134
U.S.L. 10 Villa Ognissanti
Florence, 50139
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), 16132
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), 16132
Ospedale Galliera Oncologia
Genova (Genoa), 16128
Ospedale Di Gorgonzola
Gorgonzola, 20064
Ospedale Legnago USSL 21
Legnago, 37045
Ospedale Maggiore Lodi
Lodi, I-20075
Ospedale Umberto I
Lugo DI Romagna, 48022
U.S.S.L. 72 Magenta
Magenta, 20013
Carlo Poma Hospital
Mantua, 46100
Ospedale Di Predabissi Melegnano
Melegnano, 20077
Azienda USSL NO 8
Merate, 22055
Instituto Di Oncologia
Messina, 98122
Ospedale Civile Umberto I
Mestre, 30174
Ospedale San Giuseppe
Milan, 20100
Consorzio Provinciale Antitubercolare
Milan, 20124
Istituto Scientifico H.S. Raffaele
Milan, 20132
Istituto Di Science Biomediche San Paolo
Milan, 20142
Casa Di Cura San Ambrogio
Milan, 20149
Ospedale San Carlo Borromeo
Milano (Milan), 20153
Ospedale Luigi Sacco
Milano (Milan), 20157
Ospedale Maggiore Ca Granda
Milano (Milan), 20162
Ospedale Santa Croce
Moncalieri, 10024
Nuovo Ospedale San Gerardo
Monza, 20052
Ospedale Civile Asilo Vittoria
Mortara, 27036
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
Ospedale Vincenzo Monaldi
Naples, 80131
Ospedale C. Ascalesi
Naples, 80139
Federico II University Medical School
Naples (Napoli), 80131
Istituto Tumori/Fondazione Pascale
Naples (Napoli), 80131
Ospedale Civile Negrar
Negrar, 37024
Azienda Ospedaliera di Padova
Padova (Padua), 35128
University of Padua
Padua, 35128
Ospedale Civico E Benefratelli
Palermo, 90127
Ospedale Maggiore Parma
Parma, 43100
Ospedale Torrette University Ancona
Parma, 43100
Ospedale Silvestrini
Perugia, 06132
Ospedale Agnelli
Pinerolo, 10064
Ospedale Sta. Maria Delle Croci
Ravenna, 48100
Azienda Ospedaliera
Reggio Emilia, 42100
Ospedale Civile Rho
Rho, 20017
Istituti Fisioterapici Ospitalieri - Roma
Rome, 00128
Ospedale San Filippo Neri
Rome, 00135
Ospedale Carlo Forlanini
Rome, 00149
Ospedale S. Camillo-Forlanini
Rome, 00151
Azienda Policlinico Umberto Primo
Rome, 00161
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168
Policlinico Militare Celio
Rome, 00184
ASL NO. 1 Imperiese
Sanremo, 18038
Azienda USSL No 4
Saronno, 21047
Istituto Clinica Medica
Sassari, 07100
Ospedale S.S. Annunziata
Savigliano, 12038
Ospedale Sesto San Giovanni
Sesto San Giovanni, 20099
Azienda Ospedaliera S. Maria
Terni, 05100
Ospedale Generale Prov. Boldrini
Thiene, 36016
Dispensario Igiene Sociale
Toino, 10100
Clinica Universita
Torino, 10126
Universita Torino
Torino, 10126
Ospedale S. Chiara
Trento, 38100
Ospedale San Isidoro
Trescore Balneario, 24069
Ospedale General Regional Ca Foncello
Treviso, 31100
Ospedale Maggiore dell' Universita
Trieste, 34100
Ospedale Cattinara
Trieste
Cattedra di Immunologia Clinica
Turin (TO), 10128
Universita Degli Studi di Udine
Udine, 33100
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Ospedale San Bortolo
Vicenza, 36100
About this study
Official title: Adjuvant Chemoimmunotherapy for Colorectal Cancer
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
Read the detailed description
OBJECTIVES:
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
- Conditions
- Colorectal Cancer
- Being tested
- recombinant interferon alfa, fluorouracil, leucovorin calcium, levamisole hydrochloride
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III 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.
recombinant interferon alfaBiological
fluorouracilDrug
levamisole hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Tonelli, MD, Study chair, Universita Degli Studi di Florence - Policlinico di Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003063
- Sponsor's protocol ID
- CDR0000065728
- Other IDs
- CNR-TONE-01, EU-97011
- Status last verified
- Nov 2005
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemoimmunotherapy for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00003063
- Acronym / sponsor ID
- CDR0000065728
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Nov 1991
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
Detailed description
OBJECTIVES:
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| levamisole hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Tonelli, MD study chair
Universita Degli Studi di Florence - Policlinico di Careggi
85 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant interferon alfa, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by European Institute of Oncology at 85 sites in 3 countries.
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Italy, Greece, South Korea. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 20 Sep 2013.