Unresectable Locally Advanced Squamous Cell Carcinoma of Head and NeckPMS LAD SCCHNNCT01303237
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
An observational study of Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck and LA SCCHN, run by Merck KGaA, Darmstadt, Germany at 25 sites in India.
Trial summary
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck, LA SCCHN
- What is being tested?
- Cetuximab + RT
- How many people
- 88 participants
- Where
- 25 sitesIndia
- Study dates
- 28 Feb 2011to 5 Aug 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Unresectable Locally Advanced (Stage III/ IV A or IV B) SCCHN patients found eligible to receive Cetuximab + RT
Who may be able to join
- Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority
- Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Patient willing and able to give written Informed Consent
- Patient capable of complying with study data collection procedures
Who cannot join
- Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
India25 sites
Aastha Oncology Associates
Ahmedabad, Gujarat, 380006
Navneet Memorial Centre
Ahmedabad, Gujarat, 380006
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, 462001
Meharbai TATA Memorial Hospital
Bistupur, Jamshedpur, 831001
Dr. Meenu's Clinic
Delhi, 201301
Omega Hospital
Hyderabad, Andhra Pradesh, 500034
Shanti Chandra Family Clinic
Hyderabad, Andhra Pradesh, 500034
Swarna Sai Hospital
Hyderabad, Andhra Pradesh, 500059
Bhagwan Mahaveer Cancer Hospital & Research Center
Jaipur, Rajasthan, 3020 17
SMS Hospital
Jaipur, Rajasthan, 302004
Cancer Care Centre
Jaipur, Rajasthan, 302017
Balaji Clinic & General Hospital
Jaipur, Rajasthan, 302018
Royal Cancer Institute and Research Centre
Kanpur, Uttar Pradesh, 208002
Bengal Oncology
Kolkata, West Bengal, 700031
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, 700054
Oncologist & Palliative Care Specialist Clinic
Kolkata, West Bengal, 700064
Arogya Multispeciality Clinic
Mangalore, Bangalore, 575002
Grecian Superspeciality Hospital
Mohali, Punjab, 160055
Harmony Health Care
Mohali, Punjab, 160062
SMH Curie Cancer Centre
New Delhi, Uttar Pradesh, 201010
Ruby Hall Clinic
Pune, Maharashtra, 411001
Dr S M Karandikar Hospital
Pune, Maharashtra, 411004
Dwidal Nursing Home
Pune, Maharashtra, 411004
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 500025
Regional cancer center
Sheikpura, Patna, 800014
About this study
Official title: A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN)
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.
Read the detailed description
This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be decided by the Investigators based on the locally approved label. The patients will be treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up for 3 years. The objectives of this study are to record safety and efficacy information on the treatment combination in the general population.
- Being tested
- Cetuximab + RT
- Keywords
- LA SCCHN, Cetuximab, RT, PMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab + RTDrug
Also called Erbitux
Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Serious Adverse Reactions
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
Measured: 3 years
Secondary outcomes (6)
Response Rate
Measured: 3 years
Progression Free Survival
Measured: 3 years
Duration of Locoregional Disease Control
Measured: 3 years
Overall Survival
Measured: 3 years
Response Rate
Measured: 8 weeks (Post completion of treatment duration)
Management of skin conditions due to treatment protocol
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study start28 Feb 2011
- Primary completion30 Jun 2013
- Study completion5 Aug 2014
Why it stopped: The study was discontinued due to slow recruitment and subjects not completing follow up period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced Squamous Cell Carcinoma 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., India
- Responsible party
- Sponsor
- Investigators
- Rajiv Rana, MD, Study director, Merck Ltd., India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303237
- Sponsor's protocol ID
- EMR062202-539
- Acronym
- PMS LAD SCCHN
- Status last verified
- Jun 2017
- First submitted
- 23 Feb 2011
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN)
- ClinicalTrials.gov ID
- NCT01303237
- Acronym / sponsor ID
- PMS LAD SCCHN / EMR062202-539
- Keywords
- LA SCCHN, Cetuximab, RT, PMS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to slow recruitment and subjects not completing follow up period.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., India
- Study start
- 28 Feb 2011 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 5 Aug 2014 (actual)
- First posted
- 24 Feb 2011 (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.
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.
Detailed description
This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be decided by the Investigators based on the locally approved label. The patients will be treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up for 3 years. The objectives of this study are to record safety and efficacy information on the treatment combination in the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Unresectable Locally Advanced (Stage III/ IV A or IV B) SCCHN patients found eligible to receive Cetuximab + RT
Key inclusion criteria (4 listed)
- Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority
- Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Patient willing and able to give written Informed Consent
- Patient capable of complying with study data collection procedures
Key exclusion criteria (1 listed)
- Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
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 |
|---|---|---|
| Cetuximab + RTAlso: ErbituxCetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT | Drug | – |
Primary outcome
Number of Patients with Serious Adverse Reactions
Time frame: 3 years
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
6 secondary outcomes
Response Rate
Time frame: 3 years
Progression Free Survival
Time frame: 3 years
Duration of Locoregional Disease Control
Time frame: 3 years
Overall Survival
Time frame: 3 years
Response Rate
Time frame: 8 weeks (Post completion of treatment duration)
Management of skin conditions due to treatment protocol
Time frame: 3 years
Results and safety
The study was stopped early (reason given: The study was discontinued due to slow recruitment and subjects not completing follow up period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Related trials for Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 1/2
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma
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.
Rajiv Rana, MD study director
Merck Ltd., India
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck and LA SCCHN, run by Merck KGaA, Darmstadt, Germany at 25 sites in India.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in India. 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.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to slow recruitment and subjects not completing follow up period.). 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?
Number of Patients with Serious Adverse Reactions (time frame: 3 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 Jun 2017.