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A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer (LARC)

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

nal-IRI

Surgical resection

Watch-and-wait

5-FU/LV

Oxaliplatin

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer (LARC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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).

Sites / Locations

Hospital Universitario Puerta de Hierro Majadahonda
Hospital Universitario Madrid Sanchinarro
Hospital General Universitario Gregorio Marañón
Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chemotherapy + Surgery

Chemotherapy + Watch-and-wait

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Relapse-free survival

Disease-free survival

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

Overall toxicity

acute and late toxicity of neoadjuvant treatment (chemo and chemoradiotherapy) according to the Common Toxicity Criteria (CTC) for adverse events (AE)

Full Information

NCT ID

NCT04009876

First Posted

July 3, 2019

Last Updated

December 12, 2022

Sponsor

Fundación de investigación HM

Collaborators

Syntax for Science, S.L

1. Study Identification

Unique Protocol Identification Number

NCT04009876

Brief Title

A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer

Official Title

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy NALIRINOX (5-FU/LV + Oxaliplatin + Nal-IRI) Followed by Chemoradiotherapy in Patients With Rectal Cancer in a Watch-and-wait Program

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

October 21, 2022 (Actual)

Study Completion Date

October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación de investigación HM

Collaborators

Syntax for Science, S.L

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer (LARC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy + Surgery

Arm Type

Experimental

Arm Description

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

Arm Title

Chemotherapy + Watch-and-wait

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

nal-IRI

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgical resection

Intervention Description

Surgical resection of the tumour

Intervention Type

Other

Intervention Name(s)

Watch-and-wait

Intervention Description

No surgery approach

Intervention Type

Drug

Intervention Name(s)

5-FU/LV

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

expected 8 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame