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Clinical trialNCT01515787UnknownPhase 2/PHASE3Interventional

PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery

SponsorAlliance for Clinical Trials in OncologyEnrollment1,194Colorectal Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1,073 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Tom Baker Cancer Centre

    Calgary, Alberta, Canada

  • Cross Cancer Institute

    Edmonton, Alberta, Canada

  • Bcca-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, Canada

  • Bcca-Vancouver Cancer Centre

    Vancouver, British Columbia, Canada

  • Cancercare Manitoba

    Winnipeg, Manitoba, Canada

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, Canada

  • London Regional Cancer Program

    London, Ontario, Canada

  • Lakeridge Health Oshawa

    Oshawa, Ontario, Canada

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, Canada

  • Niagara Health System-Saint Catharines General

    Saint Catharines, Ontario, Canada

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • Pei Cancer Treatment Centre-Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, Canada

  • Mcgill University Department of Oncology

    Montreal, Quebec, Canada

  • the Research Institute of the Mcgill University Health Centre (muhc)

    Montreal, Quebec, Canada

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, Canada

Israel
  • Shaare Zedek Medical Center

    Jerusalem, Israel

Switzerland
  • Kantonsspital Aarau

    Aarau, Switzerland

  • University Hospital Basel

    Basel, Switzerland

  • Oncology Institute of Southern Switzerland

    Bellinzona, Switzerland

  • Kantonsspital Graubunden

    Chur, Switzerland

  • University Hospital of Lausanne

    Lausanne, Switzerland

  • Kantonsspital Winterthur

    Winterthur, Switzerland

  • Zurich Hirslanden Klinik

    Zurich, Switzerland

  • Zurich Im Park

    Zurich, Switzerland

United States
  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States

  • Southern Cancer Center Pc-Daphne

    Daphne, Alabama, United States

  • Southern Cancer Center Pc-Mobile

    Mobile, Alabama, United States

  • Southern Cancer Center Pc-Providence

    Mobile, Alabama, United States

  • Southern Cancer Center Pc-Springhill

    Mobile, Alabama, United States

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, United States

  • Alaska Breast Care and Surgery Llc

    Anchorage, Alaska, United States

  • Alaska Oncology and Hematology Llc

    Anchorage, Alaska, United States

  • Alaska Regional Hospital

    Anchorage, Alaska, United States

  • Alaska Women'S Cancer Care

    Anchorage, Alaska, United States

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, United States

  • Anchorage Oncology Centre

    Anchorage, Alaska, United States

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, United States

  • Katmai Oncology Group

    Anchorage, Alaska, United States

  • Providence Alaska Medical Center

    Anchorage, Alaska, United States

1,033 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

FOLFOX →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Jun 2012
Primary completion
31 Dec 2022
Completion
30 Jun 2024
Last update posted
2 Feb 2024
Registered enrollment
1,194
Registry id
NCT01515787
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.