Clinical trial NCT03071198: Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy
Official title: Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectum Cancer
Keywords: Neoadjuvant Chemotherapy
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 3 years
Secondary outcomes:
measure: Surgery related mortality and complication
timeFrame: 3 years
measure: Resection rate of R0
timeFrame: 3 years
measure: Pathologic complete remission (pCR) rate
timeFrame: 3 years
measure: Tolerance after neoadjuvant treatment
timeFrame: 3 years
measure: Predictor efficacy of neoadjuvant chemotherapy for DFS
timeFrame: 3 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Cancer Hospital Affiliated to Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: Harbin Medical University
name: binbin cui
role: PRINCIPAL_INVESTIGATOR
References: