NCT00268333

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

February 9, 2009

Status Verified

May 1, 2007

Enrollment Period

5 months

First QC Date

December 20, 2005

Last Update Submit

February 6, 2009

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonadenocarcinoma of the rectumstage IV colon cancerstage III colon cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (5)

  • Overall survival

  • Disease-free survival

  • Primary site of recurrence

  • Time to recurrence

  • Quality of life

Interventions

fluorouracilDRUG
leucovorin calciumDRUG
oxaliplatinDRUG
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic disease isolated to the following lymph nodes: * Aortic * Interaortic * Celiomesenteric * Retroperitoneal, including the following sites: * Peri-uretal * Liver * Iliac * Clavicle * Mediastinum * Inguinal * Cervical * Incompletely resected disease * Recurrent disease, defined by 1 of the following criteria: * Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin * Progressive disease after cisplatin or fluorouracil * Must be able to be encompassed in radiation field PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% * Life expectancy more than 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000 /mm\^3 * Alkaline phosphatase ≤ 5 times normal * Bilirubin ≤ 2 times normal * Creatinine \< 2 times normal or creatinine clearance ≥ 40 mL/min * No peripheral neuropathy \> grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No weight loss \> 15% since diagnosis of recurrent disease * No uncontrolled heart disease * No angina * No symptomatic disease of the inferior artery * No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy * No concurrent corticosteroids

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

Sponsors & Collaborators

Study Sites (9)

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

FluorouracilLeucovorinOxaliplatinNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic ChemicalsCombined Modality TherapyTherapeutics

Study Officials

  • Laurent Mineur, MD

    Institut Sainte Catherine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

August 1, 2005

Primary Completion

January 1, 2006

Last Updated

February 9, 2009

Record last verified: 2007-05

Locations

FR(9)