Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer

NCT00227747 | Completed Phase 3 DMC

• 3 other identifiers: CDR0000445034FRE-FNCLCC-ACCORD-12/0405EU-20522
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 69

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. 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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage II rectal cancer; stage III rectal cancer

Outcome Measures

Primary Outcomes (1)

• Rate of complete surgical resection

Secondary Outcomes (6)

• Overall survival

• Disease-free survival

• Sphincter preservation

• Sphincter function

• Biological parameters that predict tumor response and treatment-related toxicity

Study Arms (2)

Radiothérapie + Xelox

EXPERIMENTAL

Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

Radiothérapie + Capécitabine

ACTIVE COMPARATOR

Drug: capecitabine; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

Interventions

capecitabine DRUG

Radiothérapie + Capécitabine; Radiothérapie + Xelox

oxaliplatin DRUG

Radiothérapie + Xelox

conventional surgery PROCEDURE

Radiothérapie + Capécitabine; Radiothérapie + Xelox

neoadjuvant therapy PROCEDURE

Radiothérapie + Capécitabine; Radiothérapie + Xelox

radiation therapy RADIATION

Radiothérapie + Capécitabine; Radiothérapie + Xelox

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (69)

Centre Hospitalier d'Abbeville

Abbeville, 80101, France

Location

Centre Hospitalier

Altkirch, 68134, France

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Hopital de Beziers

Béziers, 34525, France

Location

Centre Hospitalier de Blois

Blois, 41016, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Clinique Sainte Marie

Chalon-sur-Saône, 71100, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre Hospitalier de Gap

Gap, 05007, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital Jean Bernard

Limoges, 87042, France

Location

Centre Hospitalier General

Longjumeau, 91164, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Clinique J. B. Menis

Mâcon, 71000, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Hospitalier General Andre Boulloche

Montbéliard, 25209, France

Location

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, 93370, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Clinique Clementville

Montpellier, France

Location

Clinique Plein Ciel

Mougins, 06250, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Polyclinique du Val de Loire

Nevers, 58000, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30029, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier - Pau

Pau, 64046, France

Location

Clinique Saint - Pierre

Perpignan, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

CHU - Robert Debre

Reims, 51092, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Clinique Pasteur - Toulouse

Toulouse, 31076, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56001, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (2)

• 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.

  PMID: 20194850 RESULT

• 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.

  PMID: 28961836 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• Jean-Pierre Gerard, MD

  Centre Antoine Lacassagne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: November 8, 2005
• Primary Completion: October 22, 2008
• Study Completion: July 15, 2013
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

FR (69)