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A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903018
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Piramal Enterprises Limited

Tracking Information
First Submitted Date  ICMJE July 11, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date September 4, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • Time to onset of severe RIM (WHO Grade ≥ 3) [ Time Frame: Week 15 ]
    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)
  • Duration of severe RIM (WHO Grade>=3) [ Time Frame: Week 15 ]
    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)
  • Progression-Free Survival (PFS) [ Time Frame: 1year ]
    To assess Progression-Free Survival (PFS)
  • Overall Survival (OS) [ Time Frame: 1year ]
    To assess Overall Survival (OS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Radiation Induced Mucositis in Head and Neck Cancer
Intervention  ICMJE
  • Drug: P276-00
  • Radiation: Radiation Therapy
  • Drug: Cisplatin
Study Arms  ICMJE Experimental: P276-00
Interventions:
  • Drug: P276-00
  • Radiation: Radiation Therapy
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2013)
73
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 more than equal to 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 less than equal to 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:

    1. Absolute neutrophil count (ANC) more than equal to 1,500 cells/mm3
    2. Platelets more than equal to 100,000 cells/mm3
    3. 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)
  9. Adequate hepatic function measured within two weeks prior to enrollment defined as follows

    1. Bilirubin less than equal to 1.5 mg/dl
    2. AST less than equal to 2 times ULN
    3. ALT less than equal to 2 times ULN
  10. Adequate renal function measured within two weeks prior to enrollment and defined as follows

    1. Serum creatinine less than equal to 1.5 mg/dl
    2. Creatinine clearance (CC) more than equal to 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

Exclusion Criteria:

  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 co-morbidity, defined as:

    1. Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV
    2. Acute myocardial infarction within the last 6 months
    3. Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment
    4. 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
    5. Subjects with active tuberculosis
    6. 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 less than equal to 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 more than equal to 450 msec at screening
  10. Pregnant or breastfeeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903018
Other Study ID Numbers  ICMJE P276-00/64/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Piramal Enterprises Limited
Study Sponsor  ICMJE Piramal Enterprises Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr.Sarbani Ghosh Laskar, MD
PRS Account Piramal Enterprises Limited
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP