NCT00002523

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, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,011

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Apr 1993

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
10 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1993

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
12.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

9.9 years

First QC Date

November 1, 1999

Last Update Submit

September 1, 2016

Conditions

Colorectal Cancer

Keywords

stage II rectal cancerstage III rectal canceradenocarcinoma of the rectum

Interventions

fluorouracilDRUG
leucovorin calciumDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed resectable adenocarcinoma of the rectum * Any grade * Tumor macroscopically within 15 cm of anal margin on rigid rectoscopy * Tumor tethered or partially fixed on digital rectal exam and/or T3-4 on rectal ultrasound * No acute or subacute bowel obstruction without colostomy diversion * No chronic inflammatory disease of the ileum and/or colon * No primary adenocarcinoma of the anal canal * No distant metastasis PATIENT CHARACTERISTICS: Age: * 80 and under Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count greater than 2,000/mm\^3 * Platelet count greater than 130,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine less than 1.36 mg/dL Cardiovascular: * No angina pectoris Other: * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for adenocarcinoma of the rectum Chemotherapy * No prior chemotherapy for adenocarcinoma of the rectum Endocrine therapy * No prior endocrine therapy for adenocarcinoma of the rectum Radiotherapy * No prior radiotherapy for adenocarcinoma of the rectum Surgery * No prior surgery for adenocarcinoma of the rectum

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (35)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Hopital Civil de Charleroi

Charleroi, 6000, Belgium

Location

Centre Hospitalier Universitaire de Tivoli

La Louvière, 7100, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Centre Paul Papin

Angers, 49036, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier General

Belfort, 90000, France

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

C.H.U. de Brest

Brest, 29200, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Service Cancerologie Polyclinique Clairval

Marseille, 13009, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Clinique De Valdegour

Nîmes, 30900, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Clinique Sainte Clotilde

Sainte Clotilde, 97492, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Saint-Yves

Vannes, 56001, France

Location

Krankenhaus des Kreises Hameln-Pyrmont

Hamelin, 31785, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Hospital General Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, 08907, Spain

Location

Hospital General Gregorio Maranon

Madrid, 28007, Spain

Location

Kantonsspital Basel

Basel, CH-4000, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (13)

  • Bonnetain F, Bosset J, Gerard J, et al.: An analysis of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer on survival in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question? [Abstract] J Clin Oncol 29 (Suppl 15): A-3506, 2011.

    BACKGROUND

  • den Dulk M, Putter H, Collette L, Marijnen CAM, Folkesson J, Bosset JF, Rodel C, Bujko K, Pahlman L, van de Velde CJH. The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer. 2009 May;45(7):1175-1183. doi: 10.1016/j.ejca.2008.11.039. Epub 2009 Jan 6.

    PMID: 19128956BACKGROUND

  • Monnien F, Zaki H, Borg C, Mougin C, Bosset JF, Mercier M, Arbez-Gindre F, Kantelip B. Prognostic value of phosphorylated STAT3 in advanced rectal cancer: a study from 104 French patients included in the EORTC 22921 trial. J Clin Pathol. 2010 Oct;63(10):873-8. doi: 10.1136/jcp.2010.076414.

    PMID: 20876317RESULT

  • Tiv M, Puyraveau M, Mineur L, Calais G, Maingon P, Bardet E, Mercier M, Bosset JF. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial. Cancer Radiother. 2010 Oct;14(6-7):530-4. doi: 10.1016/j.canrad.2010.06.017. Epub 2010 Aug 24.

    PMID: 20797891RESULT

  • Collette L, Bosset JF, den Dulk M, Nguyen F, Mineur L, Maingon P, Radosevic-Jelic L, Pierart M, Calais G; European Organisation for Research and Treatment of Cancer Radiation Oncology Group. Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. J Clin Oncol. 2007 Oct 1;25(28):4379-86. doi: 10.1200/JCO.2007.11.9685.

    PMID: 17906203RESULT

  • Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829.

    PMID: 16971718RESULT

  • Bosset J, Calais G, Mineur L, et al.: Preoperative radiotherapy in rectal cancer: role and place of fluorouracil-based chemotherapy. Final results of the EORTC 22921 phase III trial. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-255, 2005.

    RESULT

  • Bosset JF, Calais G, Mineur L, et al.: Preoperative radiation (Preop RT) in rectal cancer: effect and timing of additional chemotherapy (CT) 5-year results of the EORTC 22921 trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-3505, 247s, 2005.

    RESULT

  • Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Briffaux A, Collette L. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results--EORTC 22921. J Clin Oncol. 2005 Aug 20;23(24):5620-7. doi: 10.1200/JCO.2005.02.113. Epub 2005 Jul 11.

    PMID: 16009958RESULT

  • Bosset JF, Calais G, Mineur L, et al.: Does the addition of chemotherapy (CT) to preoperative radiotherapy (preopRT) increase the pathological response in patients with resected rectal cancer: report of the 22921 EORTC phase III trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-3504, 246, 2004.

    RESULT

  • Bosset JF, Calais G, Daban A, et al.: Does the addition of chemotherapy to preoperative radiation increase acute toxicity in patients with rectal cancer: report of 22921 EORTC phase III trial . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1179, 2003.

    RESULT

  • Kouloulias VE, Bosset JF, van Tienhoven G, Davis BJ, Pierart M, Poortmans P; EORTC Radiotherapy Group. European Organization for Research and Treatment of Cancer. Quality assurance in the EORTC 22921 trial on preoperative radiotherapy with or without chemotherapy for resectable rectal cancer: evaluation of the individual case review procedure. Eur J Cancer. 2002 Sep;38(14):1849-56. doi: 10.1016/s0959-8049(02)00174-0.

    PMID: 12204666RESULT

  • Bosset JF, Calais G, Mineur L, Maingon P, Stojanovic-Rundic S, Bensadoun RJ, Bardet E, Beny A, Ollier JC, Bolla M, Marchal D, Van Laethem JL, Klein V, Giralt J, Clavere P, Glanzmann C, Cellier P, Collette L; EORTC Radiation Oncology Group. Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol. 2014 Feb;15(2):184-90. doi: 10.1016/S1470-2045(13)70599-0. Epub 2014 Jan 17.

    PMID: 24440473DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Interventions

FluorouracilLeucovorinRadiotherapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesTherapeutics

Study Officials

  • Jean-Francois Bosset, MD

    Hopital Jean Minjoz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1993

Primary Completion

March 1, 2003

Study Completion

January 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-09

Locations

DE(1)SE(1)FR(18)TU(1)ES(3)BE(5)CH(2)PL(1)NL(2)IL(1)