Rectal CancerPhase 2PIERNCT03000374
Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery
A Phase 2 study testing Panitumumab, 5Fluorouracil and Oxaliplatin in people with Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 11 sites in Spain.
Trial summary
Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of panitumumab with mFOLFOX-6 to evaluate the efficacy in… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Panitumumab, 5Fluorouracil and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 11 sitesSpain
- Study dates
- 30 May 2017to 15 Dec 2021
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form, and willingness and ability to comply with the requirements of the protocol;
- Men or women with rectal cancer, age ≥ 18 and <75 years;
- Histologically documented adenocarcinoma of the rectum. All other histologic types are excluded. A biopsy of the rectal primary tumor must be available (between 1-4), with tumor representation > 50% in each sample. The samples will be sent to Val d'Hebron Institute of Oncology (VHIO) for molecular determination. The blocks of the biopsies will be sent included in paraffin.
- Rectal cancer candidate for R0 resection with preservation of the rectal sphincter.
- Tumors with the following characteristics on high-resolution thin-slice (3 mm) MRI:
- mrT3
Show all 22Show fewer
- Tumors of the middle third, defined as tumors whose distal edge is ≤ 12 cm of the anal verge or below the peritoneal reflection and above ≥ 2 cm of the anorectal junction.
- Absence of MRF invasion, defined as a distance ≥ 1 mm between the tumor and the fascia;
- Absence of mutations in KRAS (mutations in KRAS exon 2 [codons 12/13], exon 3 [codons 59/61] and exon 4 [codon 117/146], NRAS (NRAS exon 2 [codons 12/13], exon 3 [codons 59/61] and exon 4 [codons 117/146]), BRAF (exon 15 [codon 600] and PI3KCA in exons 9 and 20
- ECOG performance status ≤ 2;
- Hematological status:
- Neutrophils (ANC) ≥ 1.5 x 109/L;
- Platelets ≥ 100 x 109/L;
- Hemoglobin ≥ 9 g/dL;
- Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN);
- Adequate liver function:
- Serum bilirubin ≤ 1.5 x ULN,
- Alkaline phosphatase < 5 x ULN,
- AST/ALT < 3 x ULN;
- Regular monitoring feasible;
- In women of childbearing potential, a negative serum pregnancy test within 1 week (7 days) before the start of study treatment;
- Women must commit to using reliable and appropriate methods of contraception for up to at least six months after the end of the study treatment (when applicable). Men with a partner of childbearing potential must agree to use a method of contraception and their partners must use another contraceptive method for the duration of the trial. Sexual abstinence will be accepted as a contraception method, with the duration and considerations stablished by the investigator
Who cannot join
- Mucinous adenocarcinoma.
- N2 lymph node involvement, defined as: 4 or more lymph nodes in the mesorectum showing morphological signs of metastatic involvement on MRI. A lymph node is considered malignant when:
- Short axis > 9 mm.
- Short axis 5-9 mm and ≥2 of the following criteria:
- i Rounded appearance. ii Heterogeneous margin. iii Heterogeneous signal intensity.
- Short axis < 5 mm AND round shape AND heterogeneous margin AND heterogeneous signal intensity.
Show all 19Show fewer
- Extramesorectal lymph node involvement: an involved extramesorectal lymph node is defined as a lymph node in the obturator area with a short axis > 8 mm, round shape and heterogeneous signal..
- Prior treatment with panitumumab or cetuximab;
- Preexisting permanent neuropathy (grade ≥ 2 NCI-CTCAE);
- Concomitant antitumor treatment not foreseen in the protocol (e.g., chemotherapy, targeted molecular therapy, immunotherapy);
- Treatment with any other investigational medicinal product within the 28 days prior to study entry;
- Other simultaneous or prior malignancy, except: i) properly treated uterine cervix carcinoma in situ, ii) basal or squamous cell skin carcinoma, iii) cancer in complete remission for a period > 5 years;
- Evidence of metastatic disease in additional studies or in the physical examination;
- Any other severe and uncontrolled nonmalignant disease, major surgery or traumatic injury in the last 28 days;
- Pregnant or breastfeeding women;
- Patients with known allergy to any excipient of the investigational products;
- Clinically significant cardiovascular disease, including myocardial infarction, unstable angina, symptomatic congestive heart failure or cardiac arrhythmia in the year before randomization in the study.
- Intestinal occlusion: In the case of intestinal occlusion, patients may be enrolled in the study after performing a derivative stoma.
- Interstitial Lung Disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hospital General Universitario de Elche
Elche, Alicante, 3203
Hospital Universitario La Paz
Madrid, 28046
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital de Sabadell
Sabadell, Barcelona, 08208
Hospital de Sant Joan Despí Moisés Broggi
Sant Joan Despí, Barcelona, 08970
Hospital Universitario Virgen del Rocío
Seville, 41013
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
About this study
Official title: Preoperative Induction Therapy With 12 Weeks of Panitumumab in Combination With mFOLFOX-6 in an Enriched Population (Quadruple Wild-Type) of Patients With mrT3 Rectal Cancer of the Middle Third With Clear Mesorectal Fascia
Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response (pCR)
Read the detailed description
Phase II, nonrandomized single-arm trial of preoperative treatment with mFOLFOX-6 and panitumumab in an enriched population of patients with rectal adenocarcinoma of intermediate risk, screened by MRI, without mutations in KRAS, BRAF, NRAS and PI3K. All patients enrolled in the study will receive 12 weeks of the investigational product (mFOLFOX-6 with panitumumab) every 14 days for six cycles, unless unacceptable toxicity occurs or progression is detected. After this treatment, response will be evaluated by diffusion-weighted MRI and endoscopy. In the absence of disease progression, patients eligible for R0 resection will undergo total mesorectal excision (TME). After surgery, patients will receive mFOLFOX6 x 6 cycles. In the case of intolerance to FOLFOX-panitumumab, disease progression or ineligibility for R0 resection, patients will receive chemoradiotherapy with capecitabine 825 mg/m2 every 12 hours concomitantly with radiotherapy (RT) with a total dose of 50.4 Gy. At the end of this treatment, patients will undergo TME between 6-8 weeks after finishing the CRT. If a patient has received 4 or more neoadjuvant cycles of FOLFOX-panitumumab before unacceptable toxicity or progression, it will be considered that the neoadjuvant treatment has been completed and the patient will have no additional neoadjuvant treatment but surgery. If the patient has received <4 cycles of neoadjuvant treatment, neoadjuvant CRT will be administered.
If a patient has an acceptable toxicity or disease progression or a R0 surgery is not possible to be performed and the patient received CRT, the patient will be followed up for 24 months, from the enrollment of the last patient in the trial, or until progression occurs, in order to assess progression-free survival and all the data regarding surgery and CRT will be recorded in the eCRF. If a patient withdraws consent and refuses to continue participating in the study, follow-up evaluations must be discontinued.
- Conditions
- Rectal Cancer
- Being tested
- Panitumumab, 5Fluorouracil, Oxaliplatin, Leucovorin
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix 20 mg/ml
Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.
5FluorouracilDrug
Also called 5-FU
Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².
OxaliplatinDrug
Also called Any marketed
Once every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU
LeucovorinDrug
Also called Any marketed
Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab + mFOLFOX-6 | Experimental | - Modified FOLFOX-6 regimen: 5-Fluorouracil (5-FU), oxaliplatin and leucovorin will be administered intravenously once every 14 days, according to the mFOLFOX-6 regimen:
Day 1: Oxaliplatin 85 mg/m² in IV infusion of 250-500 mL and leucovorin 200 mg/m² IV, both injected over two hours, followed by 5-FU 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².
- Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.
Treatment will continue until 6 cycles have been administered, followed by surgery, 5 weeks +/- 1 week after the last dose of neoadjuvant treatment Receives: Drug: Panitumumab; Drug: 5Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
Pathologic CR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0).
Measured: Up to 16-18 weeks after first treatment administration
Secondary outcomes (10)
Rates of R0 resection and free mesorectal fascia (or circumferential margin)
Measured: Up to 16-18 weeks after first treatment administration
Tumor regression grade (TRG)
the residual tumor after preoperative treatment is evaluated semi-quantitatively using the 5-point regression grading scale established by Dworak
Measured: Up to 16-18 weeks after first treatment administration
Rate of tumor downstaging (mrT versus ypT)
Measured: Up to 16-18 weeks after first treatment administration
Quality of surgery
According to the histopathology report
Measured: Up to 16-18 weeks after first treatment administration
Adverse events and changes in laboratory results
The adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA), version 18.1 or later, and evaluated using the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Measured: All AEs that occur up until 30 days after the last dose of investigational product will be recorded. Serious and nonserious AEs related with the study treatment that appear up until 30 days after the administration of the last dose should be reported.
Surgical complications
Measured: Over 30 days after surgery.
Rate of local recurrence
Measured: At 3 years after recruitment
Distant metastasis rate
Measured: At 3 years after recruitment
Disease free survival
Measured: At 3 years after recruitment
Overall survival
Measured: At 3 years after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start30 May 2017
- Primary completion31 Oct 2020
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Sponsor type
- University, hospital or other
- Collaborators
- Pivotal S.L., Amgen
- Responsible party
- Sponsor
- Investigators
- Carlos Fernández-Martos, MD, Study director, Initia Centro Oncológico Integral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000374
- Sponsor's protocol ID
- GEMCAD-1601
- Other IDs
- 2016-002333-29, 2016
- Acronym
- PIER
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2016
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Induction Therapy With 12 Weeks of Panitumumab in Combination With mFOLFOX-6 in an Enriched Population (Quadruple Wild-Type) of Patients With mrT3 Rectal Cancer of the Middle Third With Clear Mesorectal Fascia
- ClinicalTrials.gov ID
- NCT03000374
- Acronym / sponsor ID
- PIER / GEMCAD-1601
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
- Collaborators
- Pivotal S.L., Amgen
- Study start
- 30 May 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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.
Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response (pCR)
Detailed description
Phase II, nonrandomized single-arm trial of preoperative treatment with mFOLFOX-6 and panitumumab in an enriched population of patients with rectal adenocarcinoma of intermediate risk, screened by MRI, without mutations in KRAS, BRAF, NRAS and PI3K. All patients enrolled in the study will receive 12 weeks of the investigational product (mFOLFOX-6 with panitumumab) every 14 days for six cycles, unless unacceptable toxicity occurs or progression is detected. After this treatment, response will be evaluated by diffusion-weighted MRI and endoscopy. In the absence of disease progression, patients eligible for R0 resection will undergo total mesorectal excision (TME). After surgery, patients will receive mFOLFOX6 x 6 cycles. In the case of intolerance to FOLFOX-panitumumab, disease progression or ineligibility for R0 resection, patients will receive chemoradiotherapy with capecitabine 825 mg/m2 every 12 hours concomitantly with radiotherapy (RT) with a total dose of 50.4 Gy. At the end of this treatment, patients will undergo TME between 6-8 weeks after finishing the CRT. If a patient has received 4 or more neoadjuvant cycles of FOLFOX-panitumumab before unacceptable toxicity or progression, it will be considered that the neoadjuvant treatment has been completed and the patient will have no additional neoadjuvant treatment but surgery. If the patient has received <4 cycles of neoadjuvant treatment, neoadjuvant CRT will be administered.
If a patient has an acceptable toxicity or disease progression or a R0 surgery is not possible to be performed and the patient received CRT, the patient will be followed up for 24 months, from the enrollment of the last patient in the trial, or until progression occurs, in order to assess progression-free survival and all the data regarding surgery and CRT will be recorded in the eCRF. If a patient withdraws consent and refuses to continue participating in the study, follow-up evaluations must be discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab + mFOLFOX-6 | Experimental | Drug: Panitumumab, Drug: 5Fluorouracil, Drug: Oxaliplatin, Drug: Leucovorin- Modified FOLFOX-6 regimen: 5-Fluorouracil (5-FU), oxaliplatin and leucovorin will be administered intravenously once every 14 days, according to the mFOLFOX-6 regimen: Day 1: Oxaliplatin 85 mg/m² in IV infusion of 250-500 mL and leucovorin 200 mg/m² IV, both injected over two hours, followed by 5-FU 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m². - Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL. Treatment will continue until 6 cycles have been administered, followed by surgery, 5 weeks +/- 1 week after the last dose of neoadjuvant treatment |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed and dated informed consent form, and willingness and ability to comply with the requirements of the protocol;
- Men or women with rectal cancer, age ≥ 18 and <75 years;
- Histologically documented adenocarcinoma of the rectum. All other histologic types are excluded. A biopsy of the rectal primary tumor must be available (between 1-4), with tumor representation > 50% in each sample. The samples will be sent to Val d'Hebron Institute of Oncology (VHIO) for molecular determination. The blocks of the biopsies will be sent included in paraffin.
- Rectal cancer candidate for R0 resection with preservation of the rectal sphincter.
- Tumors with the following characteristics on high-resolution thin-slice (3 mm) MRI:
Key exclusion criteria (19 listed)
- Mucinous adenocarcinoma.
- N2 lymph node involvement, defined as: 4 or more lymph nodes in the mesorectum showing morphological signs of metastatic involvement on MRI. A lymph node is considered malignant when:
- i Rounded appearance. ii Heterogeneous margin. iii Heterogeneous signal intensity.
- Extramesorectal lymph node involvement: an involved extramesorectal lymph node is defined as a lymph node in the obturator area with a short axis > 8 mm, round shape and heterogeneous signal..
- Prior treatment with panitumumab or cetuximab;
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 |
|---|---|---|
| PanitumumabAlso: Vectibix 20 mg/mlPanitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL. | Drug | Panitumumab + mFOLFOX-6 |
| 5FluorouracilAlso: 5-FUOnce every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m². | Drug | Panitumumab + mFOLFOX-6 |
| OxaliplatinAlso: Any marketedOnce every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU | Drug | Panitumumab + mFOLFOX-6 |
| LeucovorinAlso: Any marketedOnce every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU | Drug | Panitumumab + mFOLFOX-6 |
Primary outcome
Pathologic complete response (pCR)
Time frame: Up to 16-18 weeks after first treatment administration
Pathologic CR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0).
10 secondary outcomes
Rates of R0 resection and free mesorectal fascia (or circumferential margin)
Time frame: Up to 16-18 weeks after first treatment administration
Tumor regression grade (TRG)
Time frame: Up to 16-18 weeks after first treatment administration
Rate of tumor downstaging (mrT versus ypT)
Time frame: Up to 16-18 weeks after first treatment administration
Quality of surgery
Time frame: Up to 16-18 weeks after first treatment administration
Adverse events and changes in laboratory results
Time frame: All AEs that occur up until 30 days after the last dose of investigational product will be recorded. Serious and nonserious AEs related with the study treatment that appear up until 30 days after the administration of the last dose should be reported.
Surgical complications
Time frame: Over 30 days after surgery.
Rate of local recurrence
Time frame: At 3 years after recruitment
Distant metastasis rate
Time frame: At 3 years after recruitment
Disease free survival
Time frame: At 3 years after recruitment
Overall survival
Time frame: At 3 years after recruitment
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 17 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Carlos Fernández-Martos, MD study director
Initia Centro Oncológico Integral
11 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 Panitumumab, 5Fluorouracil and Oxaliplatin in people with Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 11 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 22 inclusion and 19 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Pathologic complete response (pCR) (time frame: Up to 16-18 weeks after first treatment administration). 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 17 Mar 2022.