Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

NCT03071198 | Unknown DMC

• 1 other identifier: 201702230001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectum Cancer

Keywords

Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS)

  the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

  3 years

Secondary Outcomes (5)

• Surgery related mortality and complication

  3 years

• Resection rate of R0

  3 years

• Pathologic complete remission (pCR) rate

  3 years

• Tolerance after neoadjuvant treatment

  3 years

• Predictor efficacy of neoadjuvant chemotherapy for DFS

  3 years

Study Arms (3)

Preoperative neoadjuvant CT

EXPERIMENTAL

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; Drug: neoadjuvant CT; Drug: adjuvant CT

Preoperative neoadjuvant CT-RCT

EXPERIMENTAL

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; Radiation: Concurrent chemo-radiotherapy; Drug: neoadjuvant CT; Drug: adjuvant CT

Concurrent chemo-radiotherapy

ACTIVE COMPARATOR

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

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

Interventions

TME PROCEDURE

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; Preoperative neoadjuvant CT; Preoperative neoadjuvant CT-RCT

Concurrent chemo-radiotherapy RADIATION

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

Also known as: neoadjuvant RCT

Concurrent chemo-radiotherapy; Preoperative neoadjuvant CT-RCT

neoadjuvant CT DRUG

CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks

Also known as: neoadjuvant chemotherapy

Preoperative neoadjuvant CT; Preoperative neoadjuvant CT-RCT

adjuvant CT DRUG

CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks

Also known as: adjuvant chemotherapy

Concurrent chemo-radiotherapy; Preoperative neoadjuvant CT; Preoperative neoadjuvant CT-RCT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• binbin cui

  Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

binbin Cui, Doctor

CONTACT

+86-13351112888; Cuibb2017@163.com

yanlong Liu, Doctor

CONTACT

+86-13845082914; liuyanlong1979@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of colorectal surgery

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 6, 2017
• Study Start: March 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2021
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

CN (1)