- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296240
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer
Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision.
Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS).
This study is designed to recruit 119 patients in all.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xinyu Wang
- Phone Number: +8618511834100
- Email: wxy_196@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Age ≥18 years and ≤80 years
- ECOG Performance status 0-1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy;
Clinical Stage based on MRI
- mrMRF(-)
- T3c/T3d/T4a, anyN, or T3bN+
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No active infections requiring systemic antibiotic treatment
- ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria:
• Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
- The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received prior pelvic radiotherapy.
- Patients who are unable to undergo an MRI.
- Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- Other Anticancer or Experimental Therapy.
- Women who are pregnant or breast-feeding.
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Neoadjuvant chemotherapy
Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;
|
Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months
Other Names:
Patient receive total mesorectal excision after neoadjuvant chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathologic complete response rate
Time Frame: 30 days
|
the number of patients with pCR divided by the total number of patients
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 year disease-free survival
Time Frame: three years after the enrollment
|
cumulative rate of survival without cancer after 3 years follow up
|
three years after the enrollment
|
surgical complication rate
Time Frame: 30 days after the operation
|
rate of patients who had surgical complications during the perioperative period
|
30 days after the operation
|
Toxicity of neoadjuvant chemotherapy
Time Frame: 4 months
|
category and grade of adverse event during neoadjuvant chemotherapy
|
4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aiwen Wu, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Gastrointestinal Agents
- Capecitabine
- Oxaliplatin
- Antiemetics
Other Study ID Numbers
- PKUCH-R03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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