Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

Harbin Medical University

Status: Unknown

Conditions: Rectum Cancer

Treatments: Drug: adjuvant CT; Radiation: Concurrent chemo-radiotherapy; Drug: neoadjuvant CT; Procedure: TME

Study type: Interventional

Funder types: Other

Identifiers

NCT03071198

201702230001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 estimated patient

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

1 participants in 3 patient groups

Preoperative neoadjuvant CT

Experimental group

Description:

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

Treatment:

Procedure: TME

Drug: neoadjuvant CT

Drug: adjuvant CT

Preoperative neoadjuvant CT-RCT

Experimental group

Description:

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

Treatment:

Procedure: TME

Drug: neoadjuvant CT

Radiation: Concurrent chemo-radiotherapy

Drug: adjuvant CT

Concurrent chemo-radiotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: TME

Radiation: Concurrent chemo-radiotherapy

Drug: adjuvant CT