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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

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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

Brief Summary:
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Condition or disease Intervention/treatment Phase
Radiation Induced Mucositis in Head and Neck Cancer Drug: P276-00 Radiation: Radiation Therapy Drug: Cisplatin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: P276-00 Drug: P276-00
Radiation: Radiation Therapy
Drug: Cisplatin



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Progression-Free Survival (PFS) [ Time Frame: 1year ]
    To assess Progression-Free Survival (PFS)

  4. Overall Survival (OS) [ Time Frame: 1year ]
    To assess Overall Survival (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903018


Locations
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India
Bharat Cancer Hospital & Research Institute
Surat, Gujarat, India, 395010
Sri Venkateshwara Hospitals
Bangalore, Karnataka, India, 560068
Mazumdar Shaw Cancer Center
Bangalore, Karnataka, India, 560099
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Curie Manavta Cancer Centre
Nashik, Maharashtra, India, 422004
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Meenakshi Mission Hosp. & Res. Centre
Madurai, Tamil Nadu, India, 625107
Sponsors and Collaborators
Piramal Enterprises Limited
Investigators
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Principal Investigator: Dr.Sarbani Ghosh Laskar, MD

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Responsible Party: Piramal Enterprises Limited
ClinicalTrials.gov Identifier: NCT01903018     History of Changes
Other Study ID Numbers: P276-00/64/11
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Squamous Cell Carcinoma of Head and Neck
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents