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Colorectal CancerPhase 3NCT00227747

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

A Phase 3 study testing capecitabine, oxaliplatin and conventional surgery in people with Colorectal Cancer, run by UNICANCER at 69 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine, oxaliplatin and conventional surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
598 participants
Where
69 sitesFrance
Study dates
8 Nov 2005to 15 Jul 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

France69 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Centre Hospitalier

    Altkirch, 68134

  • Institut Sainte Catherine

    Avignon, 84000

  • Hopital Duffaut

    Avignon, 84902

  • Hopital de Beziers

    Béziers, 34525

  • Centre Hospitalier de Blois

    Blois, 41016

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Clinique Tivoli

    Bordeaux, F-33000

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Clinique Sainte Marie

    Chalon-sur-Saône, 71100

  • Hopital Louis Pasteur

    Chartres, 28018

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Hopital Drevon

    Dijon, 21000

  • Hopital Du Bocage

    Dijon, 21034

  • Centre Hospitalier de Gap

    Gap, 05007

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Hopital Jean Bernard

    Limoges, 87042

  • Centre Hospitalier General

    Longjumeau, 91164

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre Leon Berard

    Lyon, 69373

  • Clinique J. B. Menis

    Mâcon, 71000

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

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Centre Hospitalier General Andre Boulloche

    Montbéliard, 25209

  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil

    Montfermeil, 93370

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

    Montpellier, 34298

  • Clinique Clementville

    Montpellier

  • Clinique Plein Ciel

    Mougins, 06250

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Polyclinique du Val de Loire

    Nevers, 58000

  • Centre Antoine Lacassagne

    Nice, 06189

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

    Nîmes, 30029

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint-Louis

    Paris, 75475

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier - Pau

    Pau, 64046

  • Clinique Saint - Pierre

    Perpignan

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot

    Reims, 51056

  • CHU - Robert Debre

    Reims, 51092

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre Eugene Marquis

    Rennes, 35062

  • Centre Hospitalier de Rodez

    Rodez, 12027

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Centre Paul Strauss

    Strasbourg, 67065

  • Institut Claudius Regaud

    Toulouse, 31052

  • Clinique Pasteur - Toulouse

    Toulouse, 31076

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Centre d'Oncologie Saint-Yves

    Vannes, 56001

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

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

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.

Read the 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.

Keywords
adenocarcinoma of the rectum, stage II rectal cancer, stage III rectal cancer
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00227747
Study groupRoleWhat they receive
Radiothérapie + XeloxExperimentalNot described
Receives: Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy
Radiothérapie + CapécitabineActive comparatorNot described
Receives: Drug: capecitabine; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of complete surgical resection

Secondary outcomes (6)

  1. Overall survival

  2. Disease-free survival

  3. Sphincter preservation

  4. Sphincter function

  5. Biological parameters that predict tumor response and treatment-related toxicity

  6. Acute and late toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2005 (estimated)
  2. Study start8 Nov 2005
  3. Primary completion22 Oct 2008
  4. Study completion15 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
598 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227747
Sponsor's protocol ID
CDR0000445034
Other IDs
FRE-FNCLCC-ACCORD-12/0405, EU-20522
Status last verified
Feb 2021
First submitted
26 Sep 2005
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 20194850

  • 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.

    PubMed 28961836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, oxaliplatin and conventional surgery in people with Colorectal Cancer, run by UNICANCER at 69 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete surgical resection. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00227747, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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