Carcinoma, Squamous Cell of Head and NeckPhase 3NCT00957086
Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer
A Phase 3 study testing Nimotuzumab in people with Carcinoma, Squamous Cell of Head and Neck, run by National Cancer Centre, Singapore at 30 sites in 13 countries.
Trial summary
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 710 participants
- Where
- 30 sitesin 13 countries
- Study dates
- 13 Aug 2009to 1 Jan 2025
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age should be greater than or equal to the minimum age of consent in the applicable country
- Histologically proven head and neck squamous cell cancer (excluding nasopharynx, salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary lesion or the neck mass.
- Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of distant metastasis.
- Complete macroscopic resection.
- Patients should have at least one of the following pathological features for inclusion: pT3 or pT4 and any nodal stage (N), except T3N0 of the larynx, with negative resection margins, or a tumor stage of 1 or 2 with a nodal stage of 2 or 3 and no distant metastasis (M0); patients with stage T1 or T2 and N0 or N1 who had unfavorable pathological findings (extranodal spread, positive resection margins, perineural involvement, or vascular tumor embolism) are also eligible, as are those with oral-cavity or oropharyngeal tumors with involved lymph nodes at level IV or V.
- Performance status must be ECOG 0 or 1. Patients should be able to tolerate chemotherapy and radiotherapy.
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- Adequate bone marrow, renal and hepatic function:
- WBC>3000/mm3, platelets>100000/mm3
- Serum creatinine<upper limit of normal range as per institution and calculated creatinine clearance (according to the Cockcroft and Gault method) >50 ml/min.
- SAP, SGOT<2 x upper limit of normal range, bilirubin <1.5 x upper limit of normal range.
- Written informed consent.
Who cannot join
- Histology other than SCC or its subtype.
- Patients with disease subsite deemed suitable for organ preservation approach, namely stage III/IV laryngeal or hypopharyngeal carcinoma with not more than low-volume T4 disease; low-volume T4 disease is defined as disease not eroding into cartilage or extending not more than 1 cm into the base of tongue.
- Clinical or radiological evidence of distant metastasis.
- Uncontrolled comorbidities such as diabetes mellitis, hypertension, cardiac disease.
- Uncontrolled infection.
- Uncontrolled hypercalcemia.
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- Prior history of cancer less than 5 years ago or a synchronous primary outside the head and neck area.
- Prior treatment, head and neck radiotherapy, chemotherapy or surgery (excluding biopsy) or anti-EGFR therapy such as cetuximab/EGFR oral tyrosine kinase inhibitor.
- Patients for whom compliance with follow-up is unlikely.
Trial locations and contacts
30 sites in 13 countries.
30 sites in 13 countries
India6 sites
Apollo Hospital Bangalore
Bangalore
Narayana Hrudayalaya Hospital (Mazumdar Shaw Cancer Institute)
Bangalore
Amrita Institute of Medical Sciences
Kerala
Tata Memorial Centre
Mumbai
Christian Medical College
Tamil Nadu
Regional Cancer Center Trivandrum, India
Trivandrum
South Korea4 sites
National Cancer Center Korea
Gyeonggi-do
INHA University Hospital
Incheon
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Taiwan3 sites
China Medical University Hospital
Taichung
Taipei Med Univ Hosp [TMUH]
Taipei
Taipei Veteran General Hospital
Taipei
Thailand3 sites
National Cancer Institute Bangkok (+Chulabhorn for RT)
Bangkok
Siriraj Hospital
Bangkok
Chiang Mai Hospital
Chiang Mai
Australia2 sites
Flinders Medical Centre
Bedford Park
Peter MacCallum Cancer Centre
Melbourne, VIC 3002
Egypt2 sites
Alexandria University School of Medicine
Alexandria
National Cancer Institute, Cairo University
Cairo
Malaysia2 sites
Pantai Medical Centre, Kuala Lumpur
Kuala Lumpur
Mahkota Medical Center
Malacca
Philippines2 sites
University of Santo Tomas Hospital
Manila
St. Luke's Medical Center
Quezon City
About this study
Official title: Phase III, Double-Blind, Placebo-Controlled Study of Post-Operative Adjuvant Concurrent Chemo-Radiotherapy With or Without Nimotuzumab for Stage III/IV Head & Neck Squamous Cell Cancer
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.
Read the detailed description
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). We hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage. We have designed a phase III randomized study that includes a placebo arm. We assume a 10% increase in 2 year disease free survival (from 60% to 70%). To achieve statistical significance at 90% power, we calculate the need for 355 patients per arm, assuming also a 10% dropout rate. We aim to accomplish this study with the involvement of a multidisciplinary team of surgical, radiation and medical oncologists actively involved in the management of HNSCC coming from multiple institutions and spanning at least 12 different countries. For quality assurance we will have the involvement of Singapore Clinical Research Institute who will lead the data coordination and ensure fidelity of data collected and statistical analysis; the European Society of Therapeutic Radiation Oncology (EQUAL-ESTRO) for radiation dose and fields and an international independent panel of medical oncologist, radiation oncologist and biostatistician for the Data Monitoring Committee (DMC). This committee will monitor significant events and advise on continuation or termination of trial. Concurrent with the randomized trial, we will be collecting bio specimens including blood, tumour and saliva, pre-treatment and on completion of surgical resections. We hypothesize that there are important biomarkers including clusters of genes, cancer stem cells that will predict prognosis and treatment response. The analyses performed will be very powerful because of the large sample size, the specimens are collected prospectively and because the statistical analyses will be multivariate, incorporating not only treatment but biological and staging data.
- Being tested
- Nimotuzumab, Placebo
- Keywords
- Phase III Adjuvant Concurrent Chemo-RT +/- nimotuzumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.
PlaceboDrug
Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Active comparator | Comprising Adjuvant Cisplatin, Concurrent RT and Nimotuzumab Receives: Drug: Nimotuzumab |
| Placebo | Placebo comparator | Comprising Adjuvant Cisplatin, Concurrent RT and Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm
Measured: 5 years
Secondary outcomes (2)
To compare the overall survival between the two arms
Measured: 5 years
To assess the Toxicity Profile between the 2 arms
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study start13 Aug 2009
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Innogene Kalbiotech Pte. Ltd
- Responsible party
- Sponsor
- Investigators
- K C Soo, Prof, Study chair, National Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957086
- Sponsor's protocol ID
- IHN01
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2009
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Double-Blind, Placebo-Controlled Study of Post-Operative Adjuvant Concurrent Chemo-Radiotherapy With or Without Nimotuzumab for Stage III/IV Head & Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT00957086
- Acronym / sponsor ID
- IHN01
- Keywords
- Phase III Adjuvant Concurrent Chemo-RT +/- nimotuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Innogene Kalbiotech Pte. Ltd
- Study start
- 13 Aug 2009 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Aug 2009 (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.
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.
Detailed description
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). We hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage. We have designed a phase III randomized study that includes a placebo arm. We assume a 10% increase in 2 year disease free survival (from 60% to 70%). To achieve statistical significance at 90% power, we calculate the need for 355 patients per arm, assuming also a 10% dropout rate. We aim to accomplish this study with the involvement of a multidisciplinary team of surgical, radiation and medical oncologists actively involved in the management of HNSCC coming from multiple institutions and spanning at least 12 different countries. For quality assurance we will have the involvement of Singapore Clinical Research Institute who will lead the data coordination and ensure fidelity of data collected and statistical analysis; the European Society of Therapeutic Radiation Oncology (EQUAL-ESTRO) for radiation dose and fields and an international independent panel of medical oncologist, radiation oncologist and biostatistician for the Data Monitoring Committee (DMC). This committee will monitor significant events and advise on continuation or termination of trial. Concurrent with the randomized trial, we will be collecting bio specimens including blood, tumour and saliva, pre-treatment and on completion of surgical resections. We hypothesize that there are important biomarkers including clusters of genes, cancer stem cells that will predict prognosis and treatment response. The analyses performed will be very powerful because of the large sample size, the specimens are collected prospectively and because the statistical analyses will be multivariate, incorporating not only treatment but biological and staging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Active comparator | Drug: NimotuzumabComprising Adjuvant Cisplatin, Concurrent RT and Nimotuzumab |
| Placebo | Placebo comparator | Drug: PlaceboComprising Adjuvant Cisplatin, Concurrent RT and Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age should be greater than or equal to the minimum age of consent in the applicable country
- Histologically proven head and neck squamous cell cancer (excluding nasopharynx, salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary lesion or the neck mass.
- Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of distant metastasis.
- Complete macroscopic resection.
- Patients should have at least one of the following pathological features for inclusion: pT3 or pT4 and any nodal stage (N), except T3N0 of the larynx, with negative resection margins, or a tumor stage of 1 or 2 with a nodal stage of 2 or 3 and no distant metastasis (M0); patients with stage T1 or T2 and N0 or N1 who had unfavorable pathological findings (extranodal spread, positive resection margins, perineural involvement, or vascular tumor embolism) are also eligible, as are those with oral-cavity or oropharyngeal tumors with involved lymph nodes at level IV or V.
Key exclusion criteria (9 listed)
- Histology other than SCC or its subtype.
- Patients with disease subsite deemed suitable for organ preservation approach, namely stage III/IV laryngeal or hypopharyngeal carcinoma with not more than low-volume T4 disease; low-volume T4 disease is defined as disease not eroding into cartilage or extending not more than 1 cm into the base of tongue.
- Clinical or radiological evidence of distant metastasis.
- Uncontrolled comorbidities such as diabetes mellitis, hypertension, cardiac disease.
- Uncontrolled 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 |
|---|---|---|
| NimotuzumabAdministered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy. | Drug | Nimotuzumab |
| PlaceboAdministered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginning on first week of radiotherapy. | Drug | Placebo |
Primary outcome
To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm
Time frame: 5 years
2 secondary outcomes
To compare the overall survival between the two arms
Time frame: 5 years
To assess the Toxicity Profile between the 2 arms
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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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.
K C Soo, Prof study chair
National Cancer Centre
30 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab in people with Carcinoma, Squamous Cell of Head and Neck, run by National Cancer Centre, Singapore at 30 sites in 13 countries.
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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in India, South Korea, Taiwan, Thailand, Australia and 8 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm (time frame: 5 years). 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 9 Jan 2024.