Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

Rectum Cancer Clinical Trial

Official title:

Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071198
• Other study ID #: 201702230001
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2017
• Last updated: March 6, 2017
• Start date: March 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2017
• Source: Harbin Medical University
• Contact: binbin Cui, Doctor
• Phone: +86-13351112888
• Email: Cuibb2017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

Intervention

Procedure:
• TME
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. 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

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
• 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

Locations

Country	Name	City	State
China	Cancer Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.	3 years
Secondary	Surgery related mortality and complication	Surgery related mortality and complication	3 years
Secondary	Resection rate of R0	Resection rate of R0	3 years
Secondary	Pathologic complete remission (pCR) rate	Pathologic complete remission (pCR) rate	3 years
Secondary	Tolerance after neoadjuvant treatment	Tolerance after neoadjuvant treatment	3 years
Secondary	Predictor efficacy of neoadjuvant chemotherapy for DFS	Predictor efficacy of neoadjuvant chemotherapy for DFS	3 years