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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier d'Abbeville
  • Centre Hospitalier
  • Institut Sainte Catherine
  • Hopital Duffaut
  • Hopital de Beziers
  • Centre Hospitalier de Blois
  • Hopital Saint Andre
  • Institut Bergonie
  • Polyclinique Bordeaux Nord Aquitaine
  • Clinique Tivoli
  • Centre Hospitalier Docteur Duchenne
  • Centre Hospitalier Pierre Oudot
  • CHU de Caen
  • Centre Regional Francois Baclesse
  • Clinique Sainte Marie
  • Hopital Louis Pasteur
  • Hopital Louis Pasteur
  • Centre Hospitalier Universitaire Henri Mondor
  • Hopital Drevon
  • Hopital Du Bocage
  • Centre Hospitalier de Gap
  • Clinique Sainte-Marguerite
  • Centre Hospitalier Departemental
  • Clinique Victor Hugo
  • Hopital Robert Boulin
  • Centre Oscar Lambret
  • Centre Hospital Regional Universitaire de Limoges
  • Hopital Jean Bernard
  • Centre Hospitalier General
  • Polyclinique des Quatre Pavillons
  • Centre Leon Berard
  • Clinique J. B. Menis
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • CHU de la Timone
  • Hopital Notre-Dame de Bon Secours
  • Centre Hospitalier General Andre Boulloche
  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Clinique Clementville
  • Clinique Plein Ciel
  • Centre Hospitalier de Mulhouse
  • Centre Regional Rene Gauducheau
  • Clinique Hartmann
  • Polyclinique du Val de Loire
  • Centre Antoine Lacassagne
  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
  • CHR D'Orleans - Hopital de la Source
  • Hopital Europeen Georges Pompidou
  • Hopital Bichat - Claude Bernard
  • Hopital Saint-Louis
  • CHU Pitie-Salpetriere
  • Hopital Tenon
  • Centre Hospitalier - Pau
  • Clinique Saint - Pierre
  • Centre Hospitalier Lyon Sud
  • Institut Jean Godinot
  • CHU - Robert Debre
  • Polyclinique De Courlancy
  • Centre Eugene Marquis
  • Centre Hospitalier de Rodez
  • Clinique Armoricaine De Radiologie
  • Centre Rene Huguenin
  • Institut de Cancerologie de la Loire
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Clinique Pasteur - Toulouse
  • Centre Alexis Vautrin
  • Centre d'Oncologie Saint-Yves
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiothérapie + Xelox

Radiothérapie + Capécitabine

Arm Description

Outcomes

Primary Outcome Measures

Rate of complete surgical resection

Secondary Outcome Measures

Overall survival
Disease-free survival
Sphincter preservation
Sphincter function
Biological parameters that predict tumor response and treatment-related toxicity
Acute and late toxicity

Full Information

First Posted
September 26, 2005
Last Updated
February 15, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00227747
Brief Title
Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
Official Title
Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2005 (Actual)
Primary Completion Date
October 22, 2008 (Actual)
Study Completion Date
July 15, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
598 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiothérapie + Xelox
Arm Type
Experimental
Arm Title
Radiothérapie + Capécitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Rate of complete surgical resection
Secondary Outcome Measure Information:
Title
Overall survival
Title
Disease-free survival
Title
Sphincter preservation
Title
Sphincter function
Title
Biological parameters that predict tumor response and treatment-related toxicity
Title
Acute and late toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Gerard, MD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier d'Abbeville
City
Abbeville
ZIP/Postal Code
80101
Country
France
Facility Name
Centre Hospitalier
City
Altkirch
ZIP/Postal Code
68134
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hopital Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Hopital de Beziers
City
Beziers
ZIP/Postal Code
34525
Country
France
Facility Name
Centre Hospitalier de Blois
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33000
Country
France
Facility Name
Centre Hospitalier Docteur Duchenne
City
Boulogne Sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
Centre Hospitalier Pierre Oudot
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Sainte Marie
City
Chalon Sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Hopital Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Hospitalier de Gap
City
Gap
ZIP/Postal Code
05007
Country
France
Facility Name
Clinique Sainte-Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
F-72000
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Jean Bernard
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier General
City
Longjumeau
ZIP/Postal Code
91164
Country
France
Facility Name
Polyclinique des Quatre Pavillons
City
Lormont
ZIP/Postal Code
33310
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Clinique J. B. Menis
City
Macon
ZIP/Postal Code
71000
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Centre Hospitalier General Andre Boulloche
City
Montbeliard
ZIP/Postal Code
25209
Country
France
Facility Name
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Clinique Clementville
City
Montpellier
Country
France
Facility Name
Clinique Plein Ciel
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Hartmann
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Polyclinique du Val de Loire
City
Nevers
ZIP/Postal Code
58000
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Hospitalier - Pau
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
Clinique Saint - Pierre
City
Perpignan
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
CHU - Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35062
Country
France
Facility Name
Centre Hospitalier de Rodez
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Clinique Pasteur - Toulouse
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre d'Oncologie Saint-Yves
City
Vannes
ZIP/Postal Code
56001
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20194850
Citation
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.
Results Reference
result
PubMed Identifier
28961836
Citation
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.
Results Reference
derived

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

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