NCT04009876

Brief Summary

This is an exploratory, open-label, single arm, non-randomized, multicenter, phase II clinical trial to determine the efficacy and clinical complete response rate in patients with rectal cancer and tumor preoperative evaluation after NAC (Neoadjuvant Chemotherapy) with NALIRINOX (5-FU \[fluorouracil)/LV \[Leucovorin calcium\] + oxaliplatin + nal-IRI \[Liposomal Irinotecan\]) and chemoradiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

3.5 years

First QC Date

July 3, 2019

Last Update Submit

December 12, 2022

Conditions

Locally Advanced Rectal Cancer (LARC)

Outcome Measures

Primary Outcomes (1)

  • cCR (clinical complete response) rate in LARC ( locally advanced rectal cancer ) patients treated with chemo - chemoradiation.

    expected 8 months

Secondary Outcomes (5)

  • Overall survival

    Through the study completion (estimated to be 15 months)

  • Relapse-free survival

    Through the study completion (estimated to be 15 months)

  • Disease-free survival

    Through the study completion (estimated to be 15 months)

  • Percentage of patients that follow the "watch-and-wait" surveillance protocol

    Through the study completion (estimated to be 15 months)

  • Overall toxicity

    Through the study completion (estimated to be 15 months)

Study Arms (2)

Chemotherapy + Surgery

EXPERIMENTAL

Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and surgical resection

Drug: nal-IRIProcedure: Surgical resectionDrug: 5-FU/LVDrug: Oxaliplatin

Chemotherapy + Watch-and-wait

EXPERIMENTAL

Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and "watch-and-wait" surveillance protocol.

Drug: nal-IRIOther: Watch-and-waitDrug: 5-FU/LVDrug: Oxaliplatin

Interventions

nal-IRIDRUG

Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)

Chemotherapy + SurgeryChemotherapy + Watch-and-wait
Surgical resectionPROCEDURE

Surgical resection of the tumour

Chemotherapy + Surgery
Watch-and-waitOTHER

No surgery approach

Chemotherapy + Watch-and-wait
5-FU/LVDRUG

Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)

Chemotherapy + SurgeryChemotherapy + Watch-and-wait
OxaliplatinDRUG

Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)

Chemotherapy + SurgeryChemotherapy + Watch-and-wait

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or females, aged ≥ 18 years.
  • Agree to participate and sign voluntary written ICF (Informed Consent Form) before any study specific procedure.
  • Patients with confirmed histopathological diagnosis of rectal cancer.
  • Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch \& wait program.
  • Patients considered for neoadjuvant treatment according to usual clinical practice may also be potential candidates.
  • ECOG (Eastern Cooperative Oncology Grou)vperformance status 0 or 1.
  • Patients who can receive radiotherapy and chemotherapy.
  • No prior or concurrent malignant disease unless in complete remission for more than three years, except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma or in situ transitional bladder cell carcinoma.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test before study entry. Both women and men must agree to use a highly effective contraceptive measure throughout the treatment period and for six months after discontinuation of treatment.
  • Adequate hematologic function: hemoglobin ≥ 9g/dL; WBC (white blood cell count ) ≥ 4000/mm 3 ; neutrophils ≥ 1.5x10 9 /L; platelets ≥ 100x10 9 /L.
  • Adequate hepatic function: total bilirubin ≤ 1.5xULN; ALT / AST (Alanine aminotransferase / Aspartate aminotransferase) ≤ 2.5xULN (Upper Limit of Normality) alkaline phosphatase ≤ 3xULN.
  • Adequate renal function: creatinine ≤ 1xULN; creatinine clearance ≥ 60ml/min.
  • No peripheral neuropathy (\< Grade 2)
  • No known history of dihydropyrimidine dehydrogenase deficiency (DPD)

You may not qualify if:

  • Patients with ECOG performance status ≥ 2.
  • Stage I (T1N0M0) or stage IV (TxNxM1) AJCC (American Joint Committee on Cancer) rectal cancer.
  • Any illness that the investigator considers will substantially increase the risk if the patient participates in the study.
  • Pregnant or breast-feeding woman.
  • Chronically active hepatitis B or C virus infection.
  • Active uncontrolled infection.
  • History, within last year, or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic left ventricular ejection fraction \< 50% (assessed by multiple-gated acquisition scan or equivalent by ultrasound) or clinically significant valvular heart disease.
  • Peripheral neuropathy (\> Grade 1)
  • Known history of dihydropyrimidine dehydrogenase deficiency (DPD)
  • Known or suspected reactions to any component of the study medication (5-FU, leucovorin, irinotecan or oxaliplatin) or to components of similar chemical or biologic composition.
  • Any phycological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
  • Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule.
  • Patients that had received any previous treatment for their rectal cancer (surgery, chemotherapy or radiotherapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28022, Spain

Location

Hospital Universitario Madrid Sanchinarro

PAU de Sanchinarro, Madrid, 28050, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Interventions

irinotecan sucrosofateOxaliplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Antonio Cubillo, MD

    Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 5, 2019

Study Start

May 1, 2019

Primary Completion

October 21, 2022

Study Completion

October 21, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

ES(4)