Radiation Induced Mucositis in Head and Neck CancerPhase 2NCT01903018
A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00
A Phase 2 study testing P276-00, Radiation Therapy and Cisplatin in people with Radiation Induced Mucositis in Head and Neck Cancer, run by Piramal Enterprises Limited at 7 sites in India.
Trial summary
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Induced Mucositis in Head and Neck Cancer
- What is being tested?
- P276-00, Radiation Therapy and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 7 sitesIndia
- Study dates
- Jul 2012to Sep 2014
- 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
- Able to understand and willing to give an informed consent for the study.
- Pathologically (histologically or cytologically) confirmed (from primary tumor and/or lymph nodes), non-metastatic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx eligible for treatment with concomitant chemoradiation as first-line treatment; subjects with a history of surgical management are not eligible
- Have a plan to receive a continuous course of radiation (3DRT or IMRT) as single daily fractions of 2.0 Gy, with a cumulative radiation dose between 66 and 70 Gy. Planned radiation treatment fields must include at least 2 oral sites (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left floor of the mouth, ventral tongue, right or left lateral tongue, or soft palate), with each site receiving more than equal to 50 Gy
- Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2)
- Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 2
- Males or females aged 18 years or older
Show all 19Show fewer
- Pre-treatment dental procedures must be completed with recovery and the prophylactic insertion of gastric feeding tubes (if planned) prior to entry into the study
- Adequate bone marrow function measured within two weeks prior to enrollment based upon CBC/differential, defined as follows:
- Absolute neutrophil count (ANC) more than equal to 1,500 cells/mm3
- Platelets more than equal to 100,000 cells/mm3
- Hemoglobin (Hb) more than equal to 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hb more than equal to 8.0 g/dl prior to the start of RT is acceptable)
- Adequate hepatic function measured within two weeks prior to enrollment defined as follows
- Bilirubin less than equal to 1.5 mg/dl
- AST less than equal to 2 times ULN
- ALT less than equal to 2 times ULN
- Adequate renal function measured within two weeks prior to enrollment and defined as follows
- Serum creatinine less than equal to 1.5 mg/dl
- Creatinine clearance (CC) more than equal to 60 ml/min determined by 24-hour urine collection or estimated by the Cockcroft-Gault formula:
- Have a negative serum pregnancy test for women of childbearing potential at time of screening and negative urine pregnancy test within 72 hrs prior to first dose of study drug
Who cannot join
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition
- Prior radiation to the head and neck
- Have undergone induction CT
- History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
- Severe co-morbidity, defined as:
Show all 16Show fewer
- Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV
- Acute myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment
- Subjects known to be seropositive for human immunodeficiency virus (HIV) or subjects with Acquired Immune Deficiency Syndrome (AIDS), known current acute or chronic Hepatitis B, known Hepatitis C (antigen positive), or hepatic cirrhosis
- Subjects with active tuberculosis
- Collagen vascular disease, such as scleroderma, as this is thought to predispose subjects to increased risk for radiation-associated toxicities
- Have used any other investigational drug therapy within 1 month prior to Day 1 of study drug administration or non-recovery (to Grade less than equal to 1) from adverse effects of the investigational agent received prior to this period
- Prior allergic reaction to any of the agents administered during the course of treatment
- Have QTcF more than equal to 450 msec at screening
- Pregnant or breastfeeding women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Sri Venkateshwara Hospitals
Bangalore, Karnataka, 560068
Mazumdar Shaw Cancer Center
Bangalore, Karnataka, 560099
Meenakshi Mission Hosp. & Res. Centre
Madurai, Tamil Nadu, 625107
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Curie Manavta Cancer Centre
Nashik, Maharashtra, 422004
Ruby Hall Clinic
Pune, Maharashtra, 411001
Bharat Cancer Hospital & Research Institute
Surat, Gujarat, 395010
About this study
Official title: A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation With or Without P276-00
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Read the detailed description
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation with or without P276-00
The Phase II component will be a single arm, open label, multicenter study to assess RIM in subjects with locally advanced SCCHN treated with P276-00 in combination with radiation therapy and cisplatin. '
The Phase III component will be a randomized, assessor blinded, multicenter, two-arm study to compare the time to onset of WHO Grade ≥ 3 RIM in subjects with locally advanced SCCHN (OC, OP, HP, and L) who are receiving definitive CRT for treatment of their malignancy. Subjects receiving definitive CRT will receive weekly intravenous cisplatin administered during radiation.
- Being tested
- P276-00, Radiation Therapy, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P276-00Drug
Radiation TherapyRadiation
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| P276-00 | Experimental | Not described Receives: Drug: P276-00; Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe Radiation Induced Mucositis (WHO grade >=3)
For Phase2, to assess the incidence of severe (WHO Grade >=3) Radiation Induced Mucositis (RIM)occurring up to a cumulative radiation dose of 66 Gray (Gy) based on the WHO mucositis scale in subjects with locally advanced squamous cell carcinoma of the head and neck (SCCHN) treated with cisplatin and radiotherapy plus P276-00
- For Phase 3
- To assess and compare the incidence of severe (WHO Grade>=3) Radiation Induced Mucositis (RIM) occurring up to a cumulative radiation dose of 54 Gy based on the WHO mucositis scale
- To assess and compare the incidence of severe (WHO Grade>=3) RIM occurring up to a cumulative radiation dose of 66 Gy based on the WHO mucositis scale in subjects with locally advanced SCCHN treated with cisplatin and radiotherapy plus P276-00 or cisplatin and radiotherapy (the two treatment arms).
Measured: Week 15
Secondary outcomes (4)
Time to onset of severe RIM (WHO Grade ≥ 3)
To evaluate the time to onset of severe RIM (WHO Grade>=3) as defined by the number of days between start of study treatment and the first time that WHO Grade 3 or 4 mucositis was observed (regardless of whether it had been Grade 0,1 or 2 previously)
Measured: Week 15
Duration of severe RIM (WHO Grade>=3)
To assess the duration of severe RIM (WHO Grade>=3) as defined by the number of days from the onset of severe RIM as defined above, to the day when severe RIM resolved (first time when WHO Grade 0, 1, or 2 was observed)
Measured: Week 15
Progression-Free Survival (PFS)
To assess Progression-Free Survival (PFS)
Measured: 1year
Overall Survival (OS)
To assess Overall Survival (OS)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Induced Mucositis in Head and Neck 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.Sarbani Ghosh Laskar, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903018
- Sponsor's protocol ID
- P276-00/64/11
- Status last verified
- Sep 2014
- First submitted
- 11 Jul 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation With or Without P276-00
- ClinicalTrials.gov ID
- NCT01903018
- Acronym / sponsor ID
- P276-00/64/11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jul 2013 (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.
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Detailed description
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation with or without P276-00
The Phase II component will be a single arm, open label, multicenter study to assess RIM in subjects with locally advanced SCCHN treated with P276-00 in combination with radiation therapy and cisplatin. '
The Phase III component will be a randomized, assessor blinded, multicenter, two-arm study to compare the time to onset of WHO Grade ≥ 3 RIM in subjects with locally advanced SCCHN (OC, OP, HP, and L) who are receiving definitive CRT for treatment of their malignancy. Subjects receiving definitive CRT will receive weekly intravenous cisplatin administered during radiation.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P276-00 | Experimental | Drug: P276-00, Radiation: Radiation Therapy, Drug: Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to understand and willing to give an informed consent for the study.
- Pathologically (histologically or cytologically) confirmed (from primary tumor and/or lymph nodes), non-metastatic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx eligible for treatment with concomitant chemoradiation as first-line treatment; subjects with a history of surgical management are not eligible
- Have a plan to receive a continuous course of radiation (3DRT or IMRT) as single daily fractions of 2.0 Gy, with a cumulative radiation dose between 66 and 70 Gy. Planned radiation treatment fields must include at least 2 oral sites (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left floor of the mouth, ventral tongue, right or left lateral tongue, or soft palate), with each site receiving more than equal to 50 Gy
- Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2)
- Have an Eastern Co-operative Oncology Group (ECOG) performance status less than equal to 2
Key exclusion criteria (16 listed)
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition
- Prior radiation to the head and neck
- Have undergone induction CT
- History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
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 |
|---|---|---|
| P276-00 | Drug | P276-00 |
| Radiation Therapy | Radiation | P276-00 |
| Cisplatin | Drug | P276-00 |
Primary outcome
Number of severe Radiation Induced Mucositis (WHO grade >=3)
Time frame: Week 15
For Phase2, to assess the incidence of severe (WHO Grade >=3) Radiation Induced Mucositis (RIM)occurring up to a cumulative radiation dose of 66 Gray (Gy) based on the WHO mucositis scale in subjects with locally advanced squamous cell carcinoma of the head and neck (SCCHN) treated with cisplatin and radiotherapy plus P276-00 * For Phase 3 * To assess and compare the incidence of severe (WHO Grade>=3) Radiation Induced Mucositis (RIM) occurring up to a cumulative radiation dose of 54 Gy based on the WHO mucositis scale * To assess and compare the incidence of severe (WHO Grade>=3) RIM occurring up to a cumulative radiation dose of 66 Gy based on the WHO mucositis scale in subjects with locally advanced SCCHN treated with cisplatin and radiotherapy plus P276-00 or cisplatin and radiotherapy (the two treatment arms).
4 secondary outcomes
Time to onset of severe RIM (WHO Grade ≥ 3)
Time frame: Week 15
Duration of severe RIM (WHO Grade>=3)
Time frame: Week 15
Progression-Free Survival (PFS)
Time frame: 1year
Overall Survival (OS)
Time frame: 1year
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 4 Sep 2014.
Related trials for Radiation Induced Mucositis in Head and Neck Cancer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
Enrolling by invitationPhase 1/2
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Mucositis Oral, Head & Neck Cancer
Not yet recruiting
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer
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.
Dr.Sarbani Ghosh Laskar, MD principal investigator
7 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 P276-00, Radiation Therapy and Cisplatin in people with Radiation Induced Mucositis in Head and Neck Cancer, run by Piramal Enterprises Limited at 7 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 19 inclusion and 16 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
Number of severe Radiation Induced Mucositis (WHO grade >=3) (time frame: Week 15). 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 4 Sep 2014.