Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
NCT ID: NCT00227747
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
598 participants
INTERVENTIONAL
2005-11-08
2013-07-15
Brief Summary
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PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
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Detailed Description
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Primary
* Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms of the rate of complete surgical resection, in patients with resectable stage II or III rectal cancer.
Secondary
* Compare overall and disease-free survival of patients treated with these regimens.
* Compare clinical tumor response in patients treated with these regimens.
* Compare acute and late toxicity of these regimens in these patients.
* Determine biological parameters that predict tumor response and treatment-related toxicity in patients treated with these regimens.
* Compare sphincter preservation and function in patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine once daily 5 days a week in weeks 1-5.
* Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients also receive oxaliplatin once weekly in weeks 1-5.
All patients undergo total mesorectal excision 6 weeks after completion of chemoradiotherapy.
PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiothérapie + Xelox
capecitabine
oxaliplatin
conventional surgery
neoadjuvant therapy
radiation therapy
Radiothérapie + Capécitabine
capecitabine
conventional surgery
neoadjuvant therapy
radiation therapy
Interventions
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capecitabine
oxaliplatin
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the rectum
* T3-4, N0-2, M0 disease by endorectal ultrasound
* T2 disease located in the low rectum allowed provided lower pole is ≤ 6 cm from the anal verge
* Tumor must be accessible to digital rectal examination (i.e., tumor located at low- or mid-rectum)
* Resectable disease treatable with chemoradiotherapy
* No unresectable disease (i.e., T4 disease with high risk for incomplete gross resection \[i.e., R2\])
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 10 g/dL
Hepatic
* Alkaline phosphatase normal
* Bilirubin normal
Renal
* Creatinine ≤ 130 μmol/L
* No severe renal insufficiency
Cardiovascular
* No cardiac insufficiency
* No symptomatic coronary artery disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindication to study treatment
* Prior acute intestinal obstruction allowed provided patient underwent surgical diversion with stoma
* No history of other cancer except basal cell skin cancer or carcinoma in situ of the cervix
* No peripheral neuropathy
* No uncontrolled diabetes
* No other uncontrolled severe disease
* No geographical, social, or psychological condition that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for cancer
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for cancer
Surgery
* Not specified
Other
* No concurrent phenytoin
* No concurrent participation in another clinical trial of an experimental medical treatment
18 Years
80 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Jean-Pierre Gerard, MD
Role: STUDY_CHAIR
Centre Antoine Lacassagne
Locations
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Centre Hospitalier d'Abbeville
Abbeville, , France
Centre Hospitalier
Altkirch, , France
Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
Hopital de Beziers
Béziers, , France
Centre Hospitalier de Blois
Blois, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Clinique Sainte Marie
Chalon-sur-Saône, , France
Hopital Louis Pasteur
Chartres, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Drevon
Dijon, , France
Hopital Du Bocage
Dijon, , France
Centre Hospitalier de Gap
Gap, , France
Clinique Sainte-Marguerite
Hyères, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Centre Oscar Lambret
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Hopital Jean Bernard
Limoges, , France
Centre Hospitalier General
Longjumeau, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Clinique J. B. Menis
Mâcon, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Centre Hospitalier General Andre Boulloche
Montbéliard, , France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Clinique Clementville
Montpellier, , France
Clinique Plein Ciel
Mougins, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Polyclinique du Val de Loire
Nevers, , France
Centre Antoine Lacassagne
Nice, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Saint-Louis
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier - Pau
Pau, , France
Clinique Saint - Pierre
Perpignan, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Jean Godinot
Reims, , France
CHU - Robert Debre
Reims, , France
Polyclinique De Courlancy
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Hospitalier de Rodez
Rodez, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Pasteur - Toulouse
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Centre d'Oncologie Saint-Yves
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Gerard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahe MA, Becouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of two neoadjuvant chemoradiotherapy regimens for locally advanced rectal cancer: results of the phase III trial ACCORD 12/0405-Prodige 2. J Clin Oncol. 2010 Apr 1;28(10):1638-44. doi: 10.1200/JCO.2009.25.8376. Epub 2010 Mar 1.
Azria D, Doyen J, Jarlier M, Martel-Lafay I, Hennequin C, Etienne P, Vendrely V, Francois E, de La Roche G, Bouche O, Mirabel X, Denis B, Mineur L, Berdah J, Mahe M, Becouarn Y, Dupuis O, Lledo G, Seitz J, Bedenne L, Gourgou-Bourgade S, Juzyna B, Conroy T, Gerard J. Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer. Ann Oncol. 2017 Oct 1;28(10):2436-2442. doi: 10.1093/annonc/mdx351.
Other Identifiers
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FRE-FNCLCC-ACCORD-12/0405
Identifier Type: -
Identifier Source: secondary_id
EU-20522
Identifier Type: -
Identifier Source: secondary_id
CDR0000445034
Identifier Type: -
Identifier Source: org_study_id
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