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Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

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ClinicalTrials.gov Identifier: NCT03071198
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Binbin Cui, Harbin Medical University

Tracking Information
First Submitted Date  ICMJE February 26, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 7, 2017
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)		 Disease Free Survival (DFS) [ Time Frame: 3 years ]
the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)		 Disease Free Surviva (DFS) [ Time Frame: 5 years ]
See the efficacy and safety of neoadjuvant chemoradiation with stratification
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Surgery related mortality and complication [ Time Frame: 3 years ]
    Surgery related mortality and complication
  • Resection rate of R0 [ Time Frame: 3 years ]
    Resection rate of R0
  • Pathologic complete remission (pCR) rate [ Time Frame: 3 years ]
    Pathologic complete remission (pCR) rate
  • Tolerance after neoadjuvant treatment [ Time Frame: 3 years ]
    Tolerance after neoadjuvant treatment
  • Predictor efficacy of neoadjuvant chemotherapy for DFS [ Time Frame: 3 years ]
    Predictor efficacy of neoadjuvant chemotherapy for DFS
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy
Official Title  ICMJE Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
Brief Summary Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer
Detailed Description By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This strategy is called "neoadjuvant hierarchical treatment" based on chemotherapy for rectal cancer. All patients with T3-4N0-2M0 middle and lower rectal caner will firstly receive neoadjuvant chemotherapy consisting of four cycles of XELOX. After four cycles, the patients achieved cCR or cPR will be perform the operation. And the patients who can not achieve cCR or cPR after the four cycles, then concurrent chemoradiotherapy will be added.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectum Cancer
Intervention  ICMJE
  • Procedure: TME
    1. Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus.
    2. At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations.
  • Radiation: Concurrent chemo-radiotherapy
    Three-dimensional conformal radiotherapy as following: CTV 44Gy/22 times＋GTV1 6Gy/3 times(2Gy/time/day，5 days a week，totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day
    Other Name: neoadjuvant RCT
  • Drug: neoadjuvant CT
    CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
    Other Name: neoadjuvant chemotherapy
  • Drug: adjuvant CT
    CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
    Other Name: adjuvant chemotherapy
Study Arms  ICMJE
  • Experimental: Preoperative neoadjuvant CT
    Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
    Interventions:
    • Procedure: TME
    • Drug: neoadjuvant CT
    • Drug: adjuvant CT
  • Experimental: Preoperative neoadjuvant CT-RCT
    Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
    Interventions:
    • Procedure: TME
    • Radiation: Concurrent chemo-radiotherapy
    • Drug: neoadjuvant CT
    • Drug: adjuvant CT
  • Active Comparator: Concurrent chemo-radiotherapy
    Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
    Interventions:
    • Procedure: TME
    • Radiation: Concurrent chemo-radiotherapy
    • Drug: adjuvant CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2017)		 1
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Inclusion criteria
  • Pathologically confirmed to be rectal adenocarcinoma.
  • Distance < 10cm from the end of the tumor to the anal verge found on colonoscopy
  • Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
  • Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
  • Patients with Karnofsky score greater ≥ 70
  • WBC > 3.5 x 109/ml , PLT > 10 x 109/ml , TBIL<22.2 umol/l , BUN <7.14mmol/l , Cr<132umol/l or Ccr > 50ml/min (Evaluated using the Cockcroft-Gault formula: Creatinine clearance (male) = {(140 - age) x LBM (kg)} / {plasma creatinine (mg/dl) x 72} ; Creatinine clearance (female) = 0.85 x {(140 - age) x LBM(kg)}/ { plasma creatinine (mg/dl) x 72})
  • Patients must sign the informed consent form
  • Female subjects must be contraceptive during the trial
  • Patients who did not receive any form of chemotherapy and radiotherapy
  • No other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.)
  • Age must be equal or more than 20 and must be equal or less than 70
  • Exclusion criteria
  • Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
  • Previously received immuno-suppressive therapy
  • Participation in interventional clinical trial over the past time
  • Suffering from malignant colonic neoplasms simultaneously
  • With peripheral neuropathy(above WHO I level)
  • Affected cognitive abilities because of neurological or psychiatric abnormalities Including central nervous system metastasis
  • Medical history of severe allergies or allergic constitution
  • Severe pulmonary or heart disease history
  • Female patients who are in pregnancy or lactation and refuse contraception
  • Previously with other malignant tumors
  • Exit criteria
  • Occurrence of bleeding, obstruction, perforation and other complications
  • Occurrence of distant metastasis during the period of neoadjuvant therapy
  • Adverse reactions, not be tolerated and do not want to continue to receive treatment
  • Patients voluntarily quit
  • Capecitabine-related Grade 4 Hand-Foot Syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: binbin Cui, Doctor +86-13351112888 Cuibb2017@163.com
Contact: yanlong Liu, Doctor +86-13845082914 liuyanlong1979@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071198
Other Study ID Numbers  ICMJE 201702230001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Binbin Cui, Harbin Medical University
Study Sponsor  ICMJE Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: binbin cui Harbin Medical University
PRS Account Harbin Medical University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP