CTRI/2012/07/002783 [Registered on: 11/07/2012] Trial Registered Prospectively
Last Modified On:
03/09/2014
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Radiation Therapy
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Study to Assess Radiation Induced Mucositis in patients of Head and Neck cancer Administered Chemo-Radiation with or without P276-00
Scientific Title of Study
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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
P276-00/64/11 version 1 (03-Jan-2012)
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Alan Hatfield
Designation
Executive Vice President
Affiliation
Piramal Healthcare Limited
Address
Clinical Research & Development
Piramal Healthcare Limited
1, Nirlon Complex,
Off Western Express Highway,
Goregaon (E), Mumbai, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
91-22-3027-5002
Fax
91-22-3027-5111
Email
alan.hatfield@piramal.com
Details of Contact Person Scientific Query
Name
Dr Sandesh Sawant
Designation
Assistant Clinical Leader
Affiliation
Piramal Healthcare Limited
Address
Clinical Research & Development
Piramal Healthcare Limited
1, Nirlon Complex,
Off Western Express Highway,
Goregaon (E), Mumbai 400 063, India
Mumbai (Suburban) MAHARASHTRA 400 063 India
Phone
02230275130
Fax
02230275111
Email
sandesh.sawant@piramal.com
Details of Contact Person Public Query
Name
Dr Sandesh Sawant
Designation
Assistant Clinical Leader
Affiliation
Piramal Healthcare Limited
Address
Clinical Research & Development
Piramal Healthcare Limited
1, Nirlon Complex,
Off Western Express Highway,
Goregaon (E), Mumbai 400 063, India
Mumbai (Suburban) MAHARASHTRA 400 063 India
Phone
02230275130
Fax
02230275111
Email
sandesh.sawant@piramal.com
Source of Monetary or Material Support
Sponsor- Piramal Healthcare Limited
Primary Sponsor
Name
Piramal Healthcare Limited
Address
Piramal Healthcare Limited
1, Nirlon Complex,
Off Western Express Highway,
Goregaon (E), Mumbai 400 063, India.
Tel: +91 22 3027 5002/ 5000
Fax: +91 22 3027 5111/ 5166
Email:alan.hatfield@piramal.com
Madurai_Meenakshi Mission Hospital & Research Centre ERB_Dr K Kumar
Approved
Mahatma Gandhi Cancer Hospital & Research Institute
Approved
Nashik_Manavata_professional_EC_Dr_R_Nagarkar
Approved
Pune_Poona Medical Research Foundation EC_Dr M Jain
Approved
Regional Cancer Centre, Trivandrum, Kerala
Approved
Searoc Ethic Committe
Approved
Surat_Research Independant Ethic Comittee_Dr N Mahale
Approved
Tata Memorial Hospital
Approved
Yashoda Academy of Medical Educational Research
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Radiation induced Mucositis in Head and Neck cancer,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
None
Not Applicable
Intervention
P276-00
P276-00 will be administered at a dose of 100 mg/m2/day as an intravenous infusion in 5% dextrose over 30 minutes on Days 1 through 5 every 21 days (Week 1, Week 4 and Week 7)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
1. Able to understand and willing to give an informed consent for the study.
2. 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
3. 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 ≥ 50 Gy
4. Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2)
5. Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
6. Males or females aged 18 years or older
7. 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
8. Adequate bone marrow function measured within two weeks prior to enrollment based upon CBC/differential, defined as follows:
a) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
b) Platelets ≥ 100,000 cells/mm3
c) Hemoglobin (Hb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hb ≥ 8.0 g/dl prior to the start of RT is acceptable)
9. Adequate hepatic function measured within two weeks prior to enrollment defined as follows:
a) Bilirubin ≤ 1.5 mg/dl
b) AST ≤ 2 times ULN
c) ALT ≤ 2 times ULN
10. Adequate renal function measured within two weeks prior to enrollment and defined as follows
a) Serum creatinine ≤ 1.5 mg/dl
b) Creatinine clearance (CC) ≥ 60 ml/min determined by 24-hour urine collection or estimated by the Cockcroft-Gault formula:
11. 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
12. Willing and able to complete the daily diary questionnaire either by themselves or with assistance.
ExclusionCriteria
Details
1. Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
2. Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition
3. Prior radiation to the head and neck
4. Have undergone induction CT
5. History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
6. Severe comorbidity, defined as:
a) Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) Classification III or IV
b) Acute myocardial infarction within the last 6 months
c) Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment
d) 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
e) Subjects with active tuberculosis
f) Collagen vascular disease, such as scleroderma, as this is thought to predispose subjects to increased risk for radiation-associated toxicities
7. Have used any other investigational drug therapy within 1 month prior to Day 1 of study drug administration or non-recovery (to Grade ï‚£ 1) from adverse effects of the investigational agent received prior to this period
8. Prior allergic reaction to any of the agents administered during the course of treatment
9. Have QTcF 450 msec at screening
10. Pregnant or breastfeeding women
11. Have any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient’s safety, interfere with evaluation of the study drug, or make the subject unsuitable for the study or unable to comply with follow-up visits.
12. Sexually active female subjects of childbearing potential and male subjects with partner of child-bearing potential unwilling to use adequate contraception from the time of signing informed consent document, throughout the duration of the study and for atleast 3 months after end of study treatment or following withdrawal from the study.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
incidence of severe (WHO Grade ≥ 3) Radiation Induced Mucositis (RIM)
Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.
Secondary Outcome
Outcome
TimePoints
Time to onset of severe RIM (WHO Grade ≥ 3)
Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.
Duration of severe RIM (WHO Grade ≥ 3)
Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
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