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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
recombinant interferon alfa
fluorouracil
leucovorin calcium
levamisole hydrochloride
Sponsored by
European Institute of Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • George Papanicolaou General Hospital
  • Ospedale Bassini
  • Universita Degli Studi di Bari Policlinico
  • Spedali Civili
  • Cattedra di Oncologia Medica - Universita
  • Ospedale Oncologico A. Businco
  • Ospedale San Michele
  • Ospedale Sant Anna
  • Ospedale Valduce
  • Ospedale Di Conselice
  • Ospedale Civile Cosenza
  • Ospedale Maggiore Crema
  • Ospedale Santa Croce
  • Ospedale Civile Feltre
  • Universita di Ferrara
  • Universita Degli Studi di Firenze - Policlin. di Careggi
  • Policlinico di Careggi
  • U.S.L. 10 Villa Ognissanti
  • Istituto Nazionale per la Ricerca sul Cancro
  • Ospedale San Martino/Cliniche Universitarie Convenzionate
  • Ospedale Galliera Oncologia
  • Ospedale Di Gorgonzola
  • Ospedale Legnago USSL 21
  • Ospedale Maggiore Lodi
  • Ospedale Umberto I
  • U.S.S.L. 72 Magenta
  • Carlo Poma Hospital
  • Ospedale Di Predabissi Melegnano
  • Azienda USSL NO 8
  • Instituto Di Oncologia
  • Ospedale Civile Umberto I
  • Ospedale San Carlo Borromeo
  • Ospedale Luigi Sacco
  • Ospedale Maggiore Ca Granda
  • Ospedale San Giuseppe
  • Consorzio Provinciale Antitubercolare
  • Istituto Scientifico H.S. Raffaele
  • Istituto Di Science Biomediche San Paolo
  • Casa Di Cura San Ambrogio
  • Ospedale Santa Croce
  • Nuovo Ospedale San Gerardo
  • Ospedale Civile Asilo Vittoria
  • Federico II University Medical School
  • Istituto Tumori/Fondazione Pascale
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Ospedale Vincenzo Monaldi
  • Ospedale C. Ascalesi
  • Ospedale Civile Negrar
  • Azienda Ospedaliera di Padova
  • University of Padua
  • Ospedale Civico E Benefratelli
  • Ospedale Maggiore Parma
  • Ospedale Torrette University Ancona
  • Ospedale Silvestrini
  • Ospedale Agnelli
  • Ospedale Sta. Maria Delle Croci
  • Azienda Ospedaliera
  • Ospedale Civile Rho
  • Istituti Fisioterapici Ospitalieri - Roma
  • Ospedale San Filippo Neri
  • Ospedale Carlo Forlanini
  • Ospedale S. Camillo-Forlanini
  • Azienda Policlinico Umberto Primo
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • Policlinico Militare Celio
  • ASL NO. 1 Imperiese
  • Azienda USSL No 4
  • Istituto Clinica Medica
  • Ospedale S.S. Annunziata
  • Ospedale Sesto San Giovanni
  • Azienda Ospedaliera S. Maria
  • Ospedale Generale Prov. Boldrini
  • Dispensario Igiene Sociale
  • Clinica Universita
  • Universita Torino
  • Ospedale S. Chiara
  • Ospedale San Isidoro
  • Ospedale General Regional Ca Foncello
  • Ospedale Maggiore dell' Universita
  • Ospedale Cattinara
  • Cattedra di Immunologia Clinica
  • Universita Degli Studi di Udine
  • Ospedale di Circolo e Fondazione Macchi
  • Ospedale San Bortolo
  • Inha University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 19, 2013
Sponsor
European Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00003063
Brief Title
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Official Title
Adjuvant Chemoimmunotherapy for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Institute of Oncology

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
levamisole hydrochloride

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Tonelli, MD
Organizational Affiliation
Universita Degli Studi di Florence - Policlinico di Careggi
Official's Role
Study Chair
Facility Information:
Facility Name
George Papanicolaou General Hospital
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Ospedale Bassini
City
Balsamo Cinisello
ZIP/Postal Code
20092
Country
Italy
Facility Name
Universita Degli Studi di Bari Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Spedali Civili
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Cattedra di Oncologia Medica - Universita
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Ospedale Oncologico A. Businco
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Ospedale San Michele
City
Cagliari
ZIP/Postal Code
9100
Country
Italy
Facility Name
Ospedale Sant Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Valduce
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Di Conselice
City
Conselice
ZIP/Postal Code
48017
Country
Italy
Facility Name
Ospedale Civile Cosenza
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Ospedale Maggiore Crema
City
Crema
ZIP/Postal Code
26013
Country
Italy
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale Civile Feltre
City
Feltre
ZIP/Postal Code
32100
Country
Italy
Facility Name
Universita di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Universita Degli Studi di Firenze - Policlin. di Careggi
City
Firenze (Florence)
ZIP/Postal Code
1 (50134)
Country
Italy
Facility Name
Policlinico di Careggi
City
Firenze (Florence)
ZIP/Postal Code
50134
Country
Italy
Facility Name
U.S.L. 10 Villa Ognissanti
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Martino/Cliniche Universitarie Convenzionate
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Galliera Oncologia
City
Genova (Genoa)
ZIP/Postal Code
16128
Country
Italy
Facility Name
Ospedale Di Gorgonzola
City
Gorgonzola
ZIP/Postal Code
20064
Country
Italy
Facility Name
Ospedale Legnago USSL 21
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
Ospedale Maggiore Lodi
City
Lodi
ZIP/Postal Code
I-20075
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo DI Romagna
ZIP/Postal Code
48022
Country
Italy
Facility Name
U.S.S.L. 72 Magenta
City
Magenta
ZIP/Postal Code
20013
Country
Italy
Facility Name
Carlo Poma Hospital
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale Di Predabissi Melegnano
City
Melegnano
ZIP/Postal Code
20077
Country
Italy
Facility Name
Azienda USSL NO 8
City
Merate
ZIP/Postal Code
22055
Country
Italy
Facility Name
Instituto Di Oncologia
City
Messina
ZIP/Postal Code
98122
Country
Italy
Facility Name
Ospedale Civile Umberto I
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Ospedale San Carlo Borromeo
City
Milano (Milan)
ZIP/Postal Code
20153
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano (Milan)
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale Maggiore Ca Granda
City
Milano (Milan)
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Consorzio Provinciale Antitubercolare
City
Milano
ZIP/Postal Code
20124
Country
Italy
Facility Name
Istituto Scientifico H.S. Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Di Science Biomediche San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Casa Di Cura San Ambrogio
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Ospedale Santa Croce
City
Moncalieri
ZIP/Postal Code
10024
Country
Italy
Facility Name
Nuovo Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ospedale Civile Asilo Vittoria
City
Mortara
ZIP/Postal Code
27036
Country
Italy
Facility Name
Federico II University Medical School
City
Naples (Napoli)
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Tumori/Fondazione Pascale
City
Naples (Napoli)
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Vincenzo Monaldi
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale C. Ascalesi
City
Napoli
ZIP/Postal Code
80139
Country
Italy
Facility Name
Ospedale Civile Negrar
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova (Padua)
ZIP/Postal Code
35128
Country
Italy
Facility Name
University of Padua
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Civico E Benefratelli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Ospedale Maggiore Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Torrette University Ancona
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Ospedale Agnelli
City
Pinerolo
ZIP/Postal Code
10064
Country
Italy
Facility Name
Ospedale Sta. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Azienda Ospedaliera
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Ospedale Civile Rho
City
Rho
ZIP/Postal Code
20017
Country
Italy
Facility Name
Istituti Fisioterapici Ospitalieri - Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Ospedale San Filippo Neri
City
Rome
ZIP/Postal Code
00135
Country
Italy
Facility Name
Ospedale Carlo Forlanini
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Ospedale S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
Azienda Policlinico Umberto Primo
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Policlinico Militare Celio
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
ASL NO. 1 Imperiese
City
San Remo
ZIP/Postal Code
18038
Country
Italy
Facility Name
Azienda USSL No 4
City
Saronno
ZIP/Postal Code
21047
Country
Italy
Facility Name
Istituto Clinica Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale S.S. Annunziata
City
Savigliano
ZIP/Postal Code
12038
Country
Italy
Facility Name
Ospedale Sesto San Giovanni
City
Sesto San Giovanni
ZIP/Postal Code
20099
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale Generale Prov. Boldrini
City
Thiene
ZIP/Postal Code
36016
Country
Italy
Facility Name
Dispensario Igiene Sociale
City
Toino
ZIP/Postal Code
10100
Country
Italy
Facility Name
Clinica Universita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Universita Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale San Isidoro
City
Trescore Balneario
ZIP/Postal Code
24069
Country
Italy
Facility Name
Ospedale General Regional Ca Foncello
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Ospedale Maggiore dell' Universita
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Facility Name
Ospedale Cattinara
City
Trieste
Country
Italy
Facility Name
Cattedra di Immunologia Clinica
City
Turin (TO)
ZIP/Postal Code
10128
Country
Italy
Facility Name
Universita Degli Studi di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

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