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Radiation Therapy and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Patients With Rectal Cancer

3. juni 2020 oppdatert av: Fox Chase Cancer Center

Phase II Study: Hyperfractionated Pre-Op Chemo-Radiation for Locally Advanced Rectal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy and chemotherapy may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy followed by surgery and combination chemotherapy in treating patients who have stage II or stage III rectal cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the local recurrence rate, disease-free survival, and overall survival of patients with stage II or III rectal cancer treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection and adjuvant fluorouracil and leucovorin calcium. II. Determine the toxicity rate in patients treated with this regimen. III. Correlate failure-free survival with ultrasound-determined preoperative staging in patients treated with this regimen. IV. Determine the quality of life of patients treated with this regimen. V. Determine if toxicity due to treatment, daily stool frequency, sexual dysfunction, and disease-free survival correlates with quality of life parameters in patients treated with this regimen. VI. Correlate clinical selection criteria with ability to perform sphincter-sparing surgery in patients treated with this regimen. VII. Determine post-chemoradiotherapy pathological response, margin status, and lymph node status and correlate these factors with initial clinico-pathologic findings in patients treated with this regimen.

OUTLINE: Patients undergo pelvic radiotherapy once daily five days a week for 5 weeks followed by boost radiotherapy twice daily for 7 days. Patients also receive neoadjuvant fluorouracil IV continuously over days 1-4 and 36-40. Patients undergo surgical resection 4-6 weeks after completion of radiotherapy. At 4 weeks after surgery, patients receive adjuvant leucovorin calcium IV and fluorouracil IV once daily five days a week. Treatment continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the completion of pelvic and boost radiotherapy, at 4 weeks after completion of chemoradiotherapy (prior to surgery), and then at 3, 6, and 12 months after completion of study therapy. Patients are followed every 3 months for 2 years, every 4 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-41 patients will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

23

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Flemington, New Jersey, Forente stater, 08822
        • Hunterdon Regional Cancer Center
      • Lakewood, New Jersey, Forente stater, 08701
        • Kimball Medical Center
      • Mount Holly, New Jersey, Forente stater, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
      • Red Bank, New Jersey, Forente stater, 07701
        • Riverview Medical Center
      • Toms River, New Jersey, Forente stater, 08755
        • Community Medical Center
      • Trenton, New Jersey, Forente stater, 08629
        • St. Francis Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater, 16602
        • Bon Secours-Holy Family Health System
      • Drexel Hill, Pennsylvania, Forente stater, 19026
        • Delaware County Memorial Hospital
      • Harrisburg, Pennsylvania, Forente stater, 17105-8700
        • Pinnacle Health Hospitals
      • Johnstown, Pennsylvania, Forente stater, 15905
        • Conemaugh Memorial Hospital
      • Langhorne, Pennsylvania, Forente stater, 19047
        • Saint Mary Regional Center
      • Lansdale, Pennsylvania, Forente stater, 19446
        • North Penn Hospital
      • Paoli, Pennsylvania, Forente stater, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase Cancer Center
      • Pottstown, Pennsylvania, Forente stater, 19464
        • Pottstown Memorial Regional Cancer Center
      • Reading, Pennsylvania, Forente stater, 19612-6052
        • Reading Hospital and Medical Center
      • West Grove, Pennsylvania, Forente stater, 19390
        • Southern Chester County Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum
  • Tumor extending through bowel wall (T3) OR
  • Fixation to surrounding structures (T4) OR
  • Nodal involvement by endorectal ultrasound (N1-2)

  • Tumor extending through bowel wall, but not fixed (T3) must be:

    • At least 4 cm or at least 40% of bowel circumference OR
    • Accompanied by nodal involvement

  • Evidence of transmural penetration confirmed by 2 of the following:

    • CT scan
    • Pelvic MRI
    • Transrectal ultrasound
    • Physical exam
  • Proximal extent of tumor must not extend higher than 12 cm above dentate line and must be below pelvic peritoneal reflexion or sacral promontory
  • Regional lymph node involvement allowed
  • No distant metastases by CT scan of abdomen and pelvis or chest x-ray

PATIENT CHARACTERISTICS:

  • Age: Over 18
  • Performance status: ECOG 0-1
  • Life expectancy: At least 2 years

  • Hematopoietic:

    • Leukocyte count greater than 4,000/mm3
    • Platelet count at least 100,000/mm3
    • Hemoglobin greater than 10 g/dL

  • Hepatic:

    • SGOT and SGPT less than 1.5 times normal
    • Bilirubin less than 1.5 mg/dL
  • Renal: Creatinine less than 1.8 mg/dL

  • Other:

    • Not pregnant or nursing
    • Negative pregnancy test
    • No other prior or concurrent malignancy within the past 5 years except inactive non-melanoma skin cancer or carcinoma in situ of the cervix
    • No psychiatric condition that would preclude informed consent
    • No other serious medical illness that would limit survival

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: Not specified
  • Chemotherapy: No prior chemotherapy for rectal cancer
  • Endocrine therapy: Not specified
  • Radiotherapy: No prior radiotherapy for rectal cancer
  • Surgery: No prior surgery for rectal cancer, except diagnostic biopsy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Radiation Therapy, Chemotherapy and Surgery
Legemiddel: fluorouracil
Legemiddel: leukovorin kalsium
Stråling: strålebehandling
Fremgangsmåte: konvensjonell kirurgi

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Frequency of toxicity
Tidsramme: weekly during treatment
weekly during treatment
tolerated dose of preoperative hyperfractionated radiation and concurrent chemotherapy
Tidsramme: during radiation therapy and chemotherapy
during radiation therapy and chemotherapy

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fox Chase Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 1996

Primær fullføring (Faktiske)

1. juli 2001

Studiet fullført (Faktiske)

1. september 2018

Datoer for studieregistrering

Først innsendt

11. juli 2001

Først innsendt som oppfylte QC-kriteriene

12. april 2004

Først lagt ut (Anslag)

13. april 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000068776
  • P30CA006927 (U.S. NIH-stipend/kontrakt)
  • FCCC-96071
  • NCI-G01-1988

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Tykktarmskreft

Kliniske studier på fluorouracil

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

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