Back to resultsNeoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine
XELOX
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Concurrent Chemoradiotherapy, Sequential Therapy
Eligibility Criteria
Inclusion Criteria:
- Pathology rectal adenocarcinoma
- Distal distance of tumor from anal verge < 10cm
- TNM staging T3-4N0-2(MRI)
- No distant metastasis
- Karnofsky score≥70
- Female patients need contraception during the test
- Postmenopausal women for at least 12 months, expect pregnancy possibility
- Patients did not receive chemotherapy, radiotherapy in any form before
- No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)
Exclusion Criteria:
- Be treated by radiotherapy, chemotherapy or tumor biological therapy before
- Received immunosuppressive therapy (including corticosteroids)
- Participated in other clinical trial(s) in 1 month
- With malignant tumor of colon
- Peripheral neuropathy (WHO I level and above)
- Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
- Severe allergies or allergic history
- Severe pulmonary or heart disease
- Pregnant or lactation or refuse contraception during the test
- Suffering other malignant tumors in past
Sites / Locations
- Harbin Medical University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Concurrent chemoradiotherapy
Sequential therapy
Arm Description
Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy
XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
Local recurrence rate
Safety: Number of Participants with Adverse Events
R0 resection rate
Pathologic complete response
Full Information
NCT ID
NCT02022852
First Posted
December 9, 2013
Last Updated
December 23, 2013
Sponsor
Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02022852
Brief Title
Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer
Official Title
Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.
Detailed Description
The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge < 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, Concurrent Chemoradiotherapy, Sequential Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concurrent chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy
Arm Title
Sequential therapy
Arm Type
Experimental
Arm Description
XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Local recurrence rate
Time Frame
3 years
Title
Safety: Number of Participants with Adverse Events
Time Frame
3 years
Title
R0 resection rate
Time Frame
1 year
Title
Pathologic complete response
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Compliance
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathology rectal adenocarcinoma
Distal distance of tumor from anal verge < 10cm
TNM staging T3-4N0-2(MRI)
No distant metastasis
Karnofsky score≥70
Female patients need contraception during the test
Postmenopausal women for at least 12 months, expect pregnancy possibility
Patients did not receive chemotherapy, radiotherapy in any form before
No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)
Exclusion Criteria:
Be treated by radiotherapy, chemotherapy or tumor biological therapy before
Received immunosuppressive therapy (including corticosteroids)
Participated in other clinical trial(s) in 1 month
With malignant tumor of colon
Peripheral neuropathy (WHO I level and above)
Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
Severe allergies or allergic history
Severe pulmonary or heart disease
Pregnant or lactation or refuse contraception during the test
Suffering other malignant tumors in past
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binbin Cui, MD
Phone
+86 13351112888
Email
13351112888@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binbin Cui, MD
Organizational Affiliation
Department of Abdominal Surgery, Harbin Medical University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Cui, MD
Phone
13351112888
Email
13351112888@163.com
First Name & Middle Initial & Last Name & Degree
Binbin Cui, MD
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer
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