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Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT03443661
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Aiping Zhou, Chinese Academy of Medical Sciences

Brief Summary:
This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

Condition or disease Intervention/treatment Phase
Locally Advanced Rectal Cancer Drug: FOLFOXIRI Phase 2

Detailed Description:
In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen (FOLFOXIRI) in Patients With Locally Advanced Rectal Cancer
Actual Study Start Date : February 6, 2016
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : November 1, 2018

Arm Intervention/treatment
Experimental: FOLFOXIRI
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
Drug: FOLFOXIRI
oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals




Primary Outcome Measures :
  1. pCR [ Time Frame: 1 year ]
    Pathological complete response according to Mandard tumor regression grading


Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: 1 year ]
    R0 resection rate

  2. locoregional recurrence rate [ Time Frame: 1 year ]
    locoregional recurrence rate

  3. Safety [ Time Frame: 1 year ]
    Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed locally advanced rectal cancer;
  2. 18-70 years ;
  3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
  4. Tumor from anus >5cm and ≤15cm;
  5. ECOG=0-1;
  6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
  7. Informed consent;
  8. UGT1A1:UGT1A1*1/UGT1A1*1,UGT1A1*1/UGT1A1*28,UGT1A1*1/UGT1A1*6;

Exclusion Criteria:

  1. Clinical stage T4b or unresectable disease;
  2. History of pelvic radiotherapy;
  3. History of chemotherapy within 5 years;
  4. History of chronic diarrhea;
  5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
  6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
  7. UGT1A1:UGT1A1*28/UGT1A1*28,UGT1A1*6/UGT1A1*6;
  8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
  9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
  10. Mental illness;Pregnant or lactating women;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443661


Contacts
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Contact: Aiping Zhou, Doctor +86 13691161998 zhouap1825@126.com
Contact: Wen Zhang, Doctor +86 18611643302 wenwen0605@163.com

Locations
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China
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, China, 100021
Contact: Aiping Zhou, Doctor    +86 13691161998    zhouap1825@126.com   
Principal Investigator: Aiping Zhou, Doctor         
Sponsors and Collaborators
Aiping Zhou
Investigators
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Principal Investigator: Aiping Zhou, Doctor China National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

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Responsible Party: Aiping Zhou, Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03443661     History of Changes
Other Study ID Numbers: CH-GI-086
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aiping Zhou, Chinese Academy of Medical Sciences:
5-Fluorouracil
rectal cancer
irinotecan
oxaliplatin
neoadjuvant chemotherapy

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action