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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

Brief Summary:
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer

Condition or disease Intervention/treatment Phase
Rectum Cancer Procedure: TME Radiation: Concurrent chemo-radiotherapy Drug: neoadjuvant CT Drug: adjuvant CT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
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
Official Title: Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
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
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.

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

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
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

Active Comparator: Concurrent chemo-radiotherapy
Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
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: 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




Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 3 years ]
    the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.


Secondary Outcome Measures :
  1. Surgery related mortality and complication [ Time Frame: 3 years ]
    Surgery related mortality and complication

  2. Resection rate of R0 [ Time Frame: 3 years ]
    Resection rate of R0

  3. Pathologic complete remission (pCR) rate [ Time Frame: 3 years ]
    Pathologic complete remission (pCR) rate

  4. Tolerance after neoadjuvant treatment [ Time Frame: 3 years ]
    Tolerance after neoadjuvant treatment

  5. Predictor efficacy of neoadjuvant chemotherapy for DFS [ Time Frame: 3 years ]
    Predictor efficacy of neoadjuvant chemotherapy for DFS



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071198


Contacts
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Contact: binbin Cui, Doctor +86-13351112888 Cuibb2017@163.com
Contact: yanlong Liu, Doctor +86-13845082914 liuyanlong1979@163.com

Locations
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China, Heilongjiang
Cancer Hospital Affiliated to Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150000
Contact: binbin cui         
Sponsors and Collaborators
Harbin Medical University
Investigators
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Principal Investigator: binbin cui Harbin Medical University
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Responsible Party: Binbin Cui, Director of colorectal surgery, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03071198    
Other Study ID Numbers: 201702230001
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Binbin Cui, Harbin Medical University:
Neoadjuvant Chemotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases