Locally Advanced Rectal Cancer (LARC)Phase 2NCT04009876
A Study to Evaluate a Chemotherapy Treatment Followed by Chemo and Radiotherapy in Patients With Rectal Cancer
A Phase 2 study testing nal-IRI, Surgical resection and Watch-and-wait in people with Locally Advanced Rectal Cancer (LARC), run by Fundación de investigación HM at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- nal-IRI, Surgical resection and Watch-and-wait
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesSpain
- Study dates
- 1 May 2019to 21 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28022
Hospital Universitario Madrid Sanchinarro
PAU de Sanchinarro, Madrid, 28050
About this study
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
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.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- nal-IRI, Surgical resection, Watch-and-wait, 5-FU/LV, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nal-IRIDrug
Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
Surgical resectionProcedure or surgery
Surgical resection of the tumour
Watch-and-waitOther
No surgery approach
5-FU/LVDrug
Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
OxaliplatinDrug
Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Surgery | Experimental | Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and surgical resection Receives: Drug: nal-IRI; Procedure: Surgical resection; Drug: 5-FU/LV; Drug: 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. Receives: Drug: nal-IRI; Other: Watch-and-wait; Drug: 5-FU/LV; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cCR (clinical complete response) rate in LARC ( locally advanced rectal cancer ) patients treated with chemo - chemoradiation.
Measured: expected 8 months
Secondary outcomes (5)
Overall survival
Measured: Through the study completion (estimated to be 15 months)
Relapse-free survival
Measured: Through the study completion (estimated to be 15 months)
Disease-free survival
Measured: Through the study completion (estimated to be 15 months)
Percentage of patients that follow the "watch-and-wait" surveillance protocol
Measured: Through the study completion (estimated to be 15 months)
Overall toxicity
acute and late toxicity of neoadjuvant treatment (chemo and chemoradiotherapy) according to the Common Toxicity Criteria (CTC) for adverse events (AE)
Measured: Through the study completion (estimated to be 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 May 2019
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Collaborators
- Syntax for Science, S.L
- Responsible party
- Sponsor
- Investigators
- Antonio Cubillo, MD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009876
- Sponsor's protocol ID
- HM-RE-2017-01
- Status last verified
- Dec 2022
- First submitted
- 3 Jul 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04009876
- Acronym / sponsor ID
- HM-RE-2017-01
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Collaborators
- Syntax for Science, S.L
- Study start
- 1 May 2019 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Surgery | Experimental | Drug: nal-IRI, Procedure: Surgical resection, Drug: 5-FU/LV, Drug: OxaliplatinTreatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and surgical resection |
| Chemotherapy + Watch-and-wait | Experimental | Drug: nal-IRI, Other: Watch-and-wait, Drug: 5-FU/LV, Drug: OxaliplatinTreatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) and "watch-and-wait" surveillance protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nal-IRITreatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) | Drug | Chemotherapy + Surgery, Chemotherapy + Watch-and-wait |
| Surgical resectionSurgical resection of the tumour | Procedure or surgery | Chemotherapy + Surgery |
| Watch-and-waitNo surgery approach | Other | Chemotherapy + Watch-and-wait |
| 5-FU/LVTreatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) | Drug | Chemotherapy + Surgery, Chemotherapy + Watch-and-wait |
| OxaliplatinTreatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks) | Drug | Chemotherapy + Surgery, Chemotherapy + Watch-and-wait |
Primary outcome
cCR (clinical complete response) rate in LARC ( locally advanced rectal cancer ) patients treated with chemo - chemoradiation.
Time frame: expected 8 months
5 secondary outcomes
Overall survival
Time frame: Through the study completion (estimated to be 15 months)
Relapse-free survival
Time frame: Through the study completion (estimated to be 15 months)
Disease-free survival
Time frame: Through the study completion (estimated to be 15 months)
Percentage of patients that follow the "watch-and-wait" surveillance protocol
Time frame: Through the study completion (estimated to be 15 months)
Overall toxicity
Time frame: Through the study completion (estimated to be 15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Cubillo, MD study director
Director
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nal-IRI, Surgical resection and Watch-and-wait in people with Locally Advanced Rectal Cancer (LARC), run by Fundación de investigación HM at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cCR (clinical complete response) rate in LARC ( locally advanced rectal cancer ) patients treated with chemo - chemoradiation. (time frame: expected 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.