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Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

3. marts 2014 opdateret af: Federation Francophone de Cancerologie Digestive

Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain.

PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).

  • Induction therapy: All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks. Patients achieving complete or partial response are randomized to 1 of 2 treatment arms.
  • Arm I: Patients undergo surgery. Patients may receive 1 course of adjuvant chemotherapy (as in induction therapy) and undergo additional radiotherapy.
  • Arm II: Patients receive additional fluoroucacil and cisplatin as in induction therapy. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks.

Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:

    • Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement
    • T3, N0-N1 disease
    • Tumor extends into fifth stratum by endosonographic scan
    • Resectable disease (palliative or curative)
  • No cervical tumor
  • No T1, T2, or T4 tumors
  • No tracheo-esophageal fistula or tracheal invasion
  • No gastric cardia cancer by gastroscopy
  • No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Creatinine normal
  • WBC ≥ 3,000/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Transaminases ≥ 60%
  • Bilirubin ≤ 2.0 mg/dL
  • No cirrhosis
  • DLCO ≥ 1.5 L with or without hypoxemia at rest
  • No progressive coronary insufficiency
  • Weight loss ≤ 15%
  • No other malignancy in the past 2 years

  • Must be able to maintain sufficient enteral nutrition (2,000 calories/day)

    • Laser photodestruction, dilation, or gastric balloon allowed
  • No contraindication to radiotherapy
  • No recurring left paralysis

PRIOR CONCURRENT THERAPY:

  • No concurrent nephrotoxic or myelotoxic drugs

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federation Francophone de Cancerologie Digestive

Efterforskere

  • Studiestol: Laurent Bedenne, MD, Federation Francophone de Cancerologie Digestive

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

27. december 2006

Først indsendt, der opfyldte QC-kriterier

27. december 2006

Først opslået (Skøn)

28. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2014

Sidst verificeret

1. april 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000453783
  • FFCD-9102
  • EU-20539
  • ESSAI-FFCD-9102

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiserørskræft

Kliniske forsøg med fluorouracil

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner