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Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02942563
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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Brief Summary:
The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.

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

Detailed Description:
This is a multicenter, phase II trial to assess the efficacy/safety of triplet regimen (FOLFOXIRI) for patients with LARC. After 4 cycles of FOLFOXIRI and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of MDT,otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/M^2, bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: FOLFOXIRI
irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
 Drug: FOLFOXIRI

Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle for 4-6 cycles,

Chemoradiation for patients who are not suitable to surgery:

Pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/m², bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME.

All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.

Other Names:
  • Irinotecan
  • Oxaliplatin
  • 5-FU
  • Capecitabine


Outcome Measures
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Primary Outcome Measures :
  1. Pelvic complete resection rate [ Time Frame: Up to 10 weeks ]
    Pathologic confirmation


Secondary Outcome Measures :
  1. The rate of local control [ Time Frame: 3 years ]
    Imaging diagnosis

  2. Disease free survival (DFS) [ Time Frame: 3 years ]
    Imaging diagnosis

  3. Overall survival [ Time Frame: 3 years ]
    Record document

  4. The rate of receive chemoradiation [ Time Frame: Up to 10 weeks ]
    Record document

  5. The rate of clinical complete response after 4 cycles of FOLFOXIRI [ Time Frame: Up to 10 weeks ]
    Imaging diagnosis

  6. The rate of pathological complete response after 4 cycles of FOLFOXIRI [ Time Frame: Up to 10 weeks ]
    Pathologic confirmation

  7. The incidence of >=3 grade adverse events [ Time Frame: 2 years ]
    Common Terminology Criteria for Adverse Events v3.0 (CTCAE)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 to 75 years at diagnosis
  • Diagnosis of rectal adenocarcinoma
  • ECOG status: 0～1
  • Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
  • Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
  • Leukocytes ≥ 4.0 x109/ L,
  • Absolute neutrophil count (ANC) ≥ 2.0 x109/ L
  • Platelet count ≥ 100 x109/ L,
  • Hemoglobin (Hb) ≥ 9g/ dL.
  • Total bilirubin ≤1.5 x the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) ≤ 3 x ULN
  • Aspartate aminotransferase (AST) ≤ 3 x ULN.
  • Serum creatinine ≤ 1.5 x the ULN.
  • Signed informed consent;

Exclusion Criteria:

  • Patient had received pelvic radiotherapy
  • Patient had received systemic chemotherapy
  • Pregnant and Nursing women
  • Had metastatic disease
  • Uncontrolled co-morbid illnesses or other concurrent disease
  • Patient had second malignant disease within 5 years
  • Patients refused to signed informed consent.
Contacts and Locations
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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): NCT02942563


Contacts
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Contact: Ming Ye, Master +862168383459 renjiyeming@163.com
Contact: Qi Lu, Master +862158752345 ext 33364 luqi@renji.com

Locations
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China, Shanghai
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Ming Ye, Master    +862168383459    renjiyeming@163.com   
Contact: Qi Lu, Master    +862158752345 ext 33364    luqi@renji.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Ming Ye, Master Locations: China, Shanghai Shanghai Jiaotong University School of Medicine, Renji Hospital
More Information
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02942563    
Other Study ID Numbers: 2016CRC R-001
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Keywords provided by RenJi Hospital:
Local Advanced Rectal Cancer
Total Neoadjuvant Therapy
FOLFOXIRI
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
 Capecitabine
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors