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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227747
• Other study ID #: CDR0000445034
• Secondary ID: FRE-FNCLCC-ACCOR
• Status: Completed
• Phase: Phase 3
• Start date: November 8, 2005
• Est. completion date: July 15, 2013

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: July 15, 2013
• Est. primary completion date: October 22, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• capecitabine

• oxaliplatin

Procedure:
• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Hospitalier d'Abbeville	Abbeville
France	Centre Hospitalier	Altkirch
France	Hopital Duffaut	Avignon
France	Institut Sainte Catherine	Avignon
France	Hopital de Beziers	Beziers
France	Centre Hospitalier de Blois	Blois
France	Clinique Tivoli	Bordeaux
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu
France	Centre Regional Francois Baclesse	Caen
France	CHU de Caen	Caen
France	Clinique Sainte Marie	Chalon Sur Saone
France	Hopital Louis Pasteur	Chartres
France	Hopital Louis Pasteur	Colmar
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Drevon	Dijon
France	Hopital Du Bocage	Dijon
France	Centre Hospitalier de Gap	Gap
France	Clinique Sainte-Marguerite	Hyeres
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	Clinique J. B. Menis	Macon
France	CHU de la Timone	Marseille
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Hopital Notre-Dame de Bon Secours	Metz
France	Centre Hospitalier General Andre Boulloche	Montbeliard
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	Nimes
France	CHR D'Orleans - Hopital de la Source	Orleans
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Centre Hospitalier - Pau	Pau
France	Clinique Saint - Pierre	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU - Robert Debre	Reims
France	Institut Jean Godinot	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	Clinique Pasteur - Toulouse	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Centre d'Oncologie Saint-Yves	Vannes
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Gérard JP, Azria D, Gourgou-Bourgade S, Martel-Laffay I, Hennequin C, Etienne PL, Vendrely V, François E, de La Roche G, Bouché O, Mirabel X, Denis B, Mineur L, Berdah JF, Mahé MA, Bécouarn Y, Dupuis O, Lledo G, Montoto-Grillot C, Conroy T. Comparison of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete surgical resection
Secondary	Overall survival
Secondary	Disease-free survival
Secondary	Sphincter preservation
Secondary	Sphincter function
Secondary	Biological parameters that predict tumor response and treatment-related toxicity
Secondary	Acute and late toxicity