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Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

Sponsor
Institute of Oncology Ljubljana (Other)
Overall Status
Completed
CT.gov ID
NCT04679597
Collaborator
(none)
161
Enrollment
48
Actual Duration (Months)

Study Details

Study Description

Brief Summary

In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
161 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
total neoadjuvant therapy

Total neoadjuvant therapy consisted of 12 weeks of induction chemotherapy with CAPOX or FOLFOX, chemoradiotherapy with capecitabine and six to eight weeks of consolidation chemotherapy with CAPOX or FOLFOX prior to surgery.

Drug: Capecitabine
comparison of two treatments
Other Names:
  • oxaliplatin

    		•
    standard therapy

    Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

    Drug: Capecitabine
    comparison of two treatments
    Other Names:
  • oxaliplatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pathological complete response [during surgery]

      pathological complete response is defined as the absence of tumor cells in the surgical resection

    Secondary Outcome Measures

    1. Neoadjuvant rectal cancer score [during treatment, assessed up to 10 days]

      Neoadjuvant rectal cancer score: The NAR score was calculated using the equation [5 pN - 3(cT - pT) + 12]^2 / 9.61 and further classified as low (< 8), intermediate (8-16), or high (< 16).

    Other Outcome Measures

    1. number of participants who completed treatment [during treatment, assessed up to 10 days]

      Compliance - number of participants who completed treatment protocol

    2. number of participants with acute side effects [during treatment, assessed up to 10 days]

      Acute toxcity - number of participants with side effects during different treatment modality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • histologically proven locally advanced rectal cancer and

    • the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.

    Exclusion Criteria:

    • distant metastases,

    • concomitant malignancy,

    • inflammatory bowel disease, or

    • malabsorption syndrome.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Institute of Oncology Ljubljana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Oncology Ljubljana
    ClinicalTrials.gov Identifier:
    NCT04679597
    Other Study ID Numbers:
    • ERID-KSOPKR-0009/2019
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Rectal Neoplasms
    Capecitabine
    Oxaliplatin

    Study Results

    No Results Posted as of Dec 24, 2020