Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy
NCT ID: NCT03071198
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1 participants
INTERVENTIONAL
2017-03-01
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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
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.
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
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
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
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.
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
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
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
Concurrent chemo-radiotherapy
Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
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.
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
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
Interventions
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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.
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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
70 Years
ALL
Yes
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Binbin Cui
Director of colorectal surgery
Principal Investigators
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binbin cui
Role: PRINCIPAL_INVESTIGATOR
Harbin Medical University
Locations
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Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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binbin cui
Role: primary
Other Identifiers
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201702230001
Identifier Type: -
Identifier Source: org_study_id
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