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Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

Primary Purpose

Rectum Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TME

Concurrent chemo-radiotherapy

neoadjuvant CT

adjuvant CT

About this trial

This is an interventional treatment trial for Rectum Cancer focused on measuring Neoadjuvant Chemotherapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cancer Hospital Affiliated to Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Preoperative neoadjuvant CT

Preoperative neoadjuvant CT-RCT

Concurrent chemo-radiotherapy

Arm 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

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

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

Outcomes

Primary Outcome Measures

Disease Free Survival (DFS)

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

Secondary Outcome Measures

Surgery related mortality and complication

Resection rate of R0

Pathologic complete remission (pCR) rate

Tolerance after neoadjuvant treatment

Predictor efficacy of neoadjuvant chemotherapy for DFS

Full Information

NCT ID

NCT03071198

First Posted

February 26, 2017

Last Updated

March 6, 2017

Sponsor

Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03071198

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

September 30, 2018 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectum Cancer

Keywords

Neoadjuvant Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preoperative neoadjuvant CT

Arm Type

Experimental

Arm 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

Arm Title

Preoperative neoadjuvant CT-RCT

Arm Type

Experimental

Arm Description

Arm Title

Concurrent chemo-radiotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

TME

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Concurrent chemo-radiotherapy

Other Intervention Name(s)

neoadjuvant RCT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

neoadjuvant CT

Other Intervention Name(s)

neoadjuvant chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

adjuvant CT

Other Intervention Name(s)

adjuvant chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease Free Survival (DFS)

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Surgery related mortality and complication

Description

Surgery related mortality and complication

Time Frame

3 years

Title

Resection rate of R0

Description

Resection rate of R0

Time Frame

3 years

Title

Pathologic complete remission (pCR) rate

Description

Pathologic complete remission (pCR) rate

Time Frame

3 years

Title

Tolerance after neoadjuvant treatment

Description

Tolerance after neoadjuvant treatment

Time Frame

3 years

Title

Predictor efficacy of neoadjuvant chemotherapy for DFS

Description

Predictor efficacy of neoadjuvant chemotherapy for DFS

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

binbin Cui, Doctor

Phone

+86-13351112888

Cuibb2017@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

yanlong Liu, Doctor

Phone

+86-13845082914

liuyanlong1979@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

binbin cui

Organizational Affiliation

Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital Affiliated to Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

binbin cui

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

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