Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT02942563 | Unknown Phase 2

• 1 other identifier: 2016CRC R-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Local Advanced Rectal Cancer; Total Neoadjuvant Therapy; FOLFOXIRI

Outcome Measures

Primary Outcomes (1)

• Pelvic complete resection rate

  Pathologic confirmation

  Up to 10 weeks

Secondary Outcomes (7)

• The rate of local control

  3 years

• Disease free survival (DFS)

  3 years

• Overall survival

  3 years

• The rate of receive chemoradiation

  Up to 10 weeks

• The rate of clinical complete response after 4 cycles of FOLFOXIRI

  Up to 10 weeks

Study Arms (1)

FOLFOXIRI

EXPERIMENTAL

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

Interventions

FOLFOXIRI DRUG

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.

Also known as: Irinotecan, Oxaliplatin, 5-FU, Capecitabine

FOLFOXIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

FOLFOXIRI protocol; Irinotecan; Oxaliplatin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ming Ye, Master

  Locations: China, Shanghai Shanghai Jiaotong University School of Medicine, Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Ye, Master

CONTACT

+862168383459; renjiyeming@163.com

Qi Lu, Master

CONTACT

+862158752345; luqi@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: November 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2022
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

CN (1)