search
Back to results

A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT

Primary Purpose

Rectal Cancer, Radiotherapy

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Short-course radiotherapy
FOLFOX4 chemotherapy,preoperative
Radiotherapy of neo-adjuvant therapy
Concurrent chemotherapy of neo-adjuvant therapy
Radical rectal cancer resection
FOLFOX4 chemotherapy,post-operative
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer, Radiotherapy focused on measuring rectal cancer, radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Consent to this study
  • 2. Histological or cytological confirmed diagnostic of rectal carcinoma
  • 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
  • 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
  • 5.With no presence of other organ metastasis or extra-regional lymph node involvement
  • 6.With no history of chemotherapy
  • 7.ECOG score is 0 or 1
  • 8.Adequate ability of bone marrow, liver and kidney function
  • 9.No pregnancy

Exclusion Criteria:

  1. Unable to intake oral medicine
  2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ;Congestive Heart Failure NYHA II grade or severe
  3. HIV infection or Active chronic HBV or HCV
  4. Severe clinical infection at active stage
  5. Epileptic seizure need treatment
  6. History of organ transplantation
  7. Renal failure or intaking renal dialysis
  8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
  9. Severe unhealed wound or skin ulcer or bone fraction
  10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years

12.Chronic inflammatory bowel disease, bowel obstruction,hereditary fructose intolerance 13.Medicine abuse;medical,psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Preoperative chemotherapy with short-course radiotherapy

    Preoperative neo-adjuvant therapy

    Arm Description

    Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy

    Preoperative treatment:neo-adjuvant therapy

    Outcomes

    Primary Outcome Measures

    Pathological Response
    Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)

    Secondary Outcome Measures

    3-year Disease-Free Survival
    time from radical resection to recurrence or end of follow-up
    3-year Overall Survival
    time from radical resection to cancer caused death or end of follow-up

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    October 21, 2016
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02941562
    Brief Title
    A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    5. Study Description

    Brief Summary
    The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
    Detailed Description
    This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer, Radiotherapy
    Keywords
    rectal cancer, radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoperative chemotherapy with short-course radiotherapy
    Arm Type
    Experimental
    Arm Description
    Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
    Arm Title
    Preoperative neo-adjuvant therapy
    Arm Type
    Active Comparator
    Arm Description
    Preoperative treatment:neo-adjuvant therapy
    Intervention Type
    Radiation
    Intervention Name(s)
    Short-course radiotherapy
    Intervention Description
    Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFOX4 chemotherapy,preoperative
    Intervention Description
    FOLFOX4 chemotherapy:5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy of neo-adjuvant therapy
    Intervention Description
    Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
    Intervention Type
    Drug
    Intervention Name(s)
    Concurrent chemotherapy of neo-adjuvant therapy
    Intervention Description
    Capecitabine 825mg/m2 twice daily 5 days/week
    Intervention Type
    Procedure
    Intervention Name(s)
    Radical rectal cancer resection
    Intervention Description
    Radical rectal cancer resection
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFOX4 chemotherapy,post-operative
    Intervention Description
    FOLFOX4 chemotherapy:5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks
    Primary Outcome Measure Information:
    Title
    Pathological Response
    Description
    Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
    Time Frame
    Surgery
    Secondary Outcome Measure Information:
    Title
    3-year Disease-Free Survival
    Description
    time from radical resection to recurrence or end of follow-up
    Time Frame
    3 years
    Title
    3-year Overall Survival
    Description
    time from radical resection to cancer caused death or end of follow-up
    Time Frame
    3 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Consent to this study 2. Histological or cytological confirmed diagnostic of rectal carcinoma 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI) 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction 5.With no presence of other organ metastasis or extra-regional lymph node involvement 6.With no history of chemotherapy 7.ECOG score is 0 or 1 8.Adequate ability of bone marrow, liver and kidney function 9.No pregnancy Exclusion Criteria: Unable to intake oral medicine Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ;Congestive Heart Failure NYHA II grade or severe HIV infection or Active chronic HBV or HCV Severe clinical infection at active stage Epileptic seizure need treatment History of organ transplantation Renal failure or intaking renal dialysis Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics Severe unhealed wound or skin ulcer or bone fraction Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years 12.Chronic inflammatory bowel disease, bowel obstruction,hereditary fructose intolerance 13.Medicine abuse;medical,psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Long Cui, MD.PhD.
    Phone
    +86-25077850
    Email
    longcuidr@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT

    We'll reach out to this number within 24 hrs