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Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer

Primary Purpose

Carcinoma of the Head and Neck

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IMRT
Sponsored by
Nilam Ramsinghani
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of the Head and Neck focused on measuring Carcinoma of the head and neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have pathologically confirmed recurrence (reappearance of previously cleared) of a squamous cell cancer primary located in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than 6 months following the end of the prior RT. Pathology slides from primary as well as recurrence must to be obtained for review by UCI Department of Pathology to confirm histology and patient eligibility. Previous radiation records including simulation and portal films must be submitted to the UCI Department of Radiation Oncology for review of treated areas and to assure that spinal cord tolerance is not exceeded. The recurrence or second primary must have defined bidimensional measurement as follows: All tumor measurements must be recorded in centimeters and should consist of the two longest perpendicular cross-diameters. Patients will be separately assessed for response by physical exam and by CT scan with contrast (unless contraindicated) or MRI scan with T1 contrast with gadolinium (unless contraindicated) and T2 sequences prior to and two months following completion of therapy. Both the clinical (physical exam) and radiographic (CT or MRI) response will be recorded on the study forms. Recurrence or second primary must be confined to the head and neck above the clavicle. The patient must not be a candidate for or refuses complete surgical (re)resection. The majority (>75%) of the tumor volume must have been in areas previously irradiated to >45 Gy. The previous irradiation must not exceed a maximum of 75 Gy. Primary and recurrent cancer treatment cumulative radiation dose must limit total spinal cord dose to 50 Gy. Patients must be at least 1 month from prior chemotherapy and radiation therapy. Karnofsky status 60 or greater. (appendix) WBC >4000/mm3, granulocytes >2,000/mm3, platelets >100,000/mm3, serum bilirubin <1.5 mg/dl, creatinine <1.8 mg/dl within one month from enrollment in protocol. If liver chemistries are above normal limits, a liver ultrasound or CT will be required. Patient must not have a history of other invasive malignancies within the past five years, excluding non-melanomatous skin cancer or cervical cancer in-situ. Exclusion Criteria Distant metastases. History of other invasive malignancies within the past five years excluding non-melanomatous skin cancer or cervical cancer in-situ. Medical condition, which would impede patient tolerance of therapy, completion of therapy or limit survival. Women who are pregnant will be excluded from this trial. A pregnancy test will be offered to women of child bearing age who are otherwise eligible for the protocol. Patients under 18 years of age will be excluded since head and neck cancer is unlikely and due to risk of long term toxicity from radiation including secondary malignancy Patients on any treatment currently for the recurrent head and neck cancer Patients have any untreated infection Patients are candidate for complete surgical resection. Patients have the previous irradiation exceeded a maximum of 75 Gy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Identify acute and late toxicities and response rates

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2005
    Last Updated
    July 26, 2017
    Sponsor
    Nilam Ramsinghani
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00257335
    Brief Title
    Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer
    Official Title
    A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to no patient enrollment this study was withdrawn/closed
    Study Start Date
    October 14, 2004 (undefined)
    Primary Completion Date
    June 12, 2007 (Actual)
    Study Completion Date
    June 12, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nilam Ramsinghani

    4. Oversight

    5. Study Description

    Brief Summary
    To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment of previously irradiated recurrent head and neck cancer. Specific Aims: Identify acute and late toxicities, response rates, locoregional control, disease free survival, and overall survival with IMRT. Also, tumor response, the amount of tumor shrinkage or reduction, will be analyzed. Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been used as a treatment modality. However, the re-irradiation dose is limited by significant toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate dose. The number of subjects was determined from 2 stage design with a historical control group as comparison, and these numbers of subjects were found to be 40. It is assumed that this treatment regimen will not be of further interest if the true response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of 53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and neck cancer. The type I error (the probability of rejecting the hypothesis that the proportion responding to the treatment is less than or equal to Po when this hypothesis is actually true) is 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma of the Head and Neck
    Keywords
    Carcinoma of the head and neck

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    IMRT
    Primary Outcome Measure Information:
    Title
    Identify acute and late toxicities and response rates

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have pathologically confirmed recurrence (reappearance of previously cleared) of a squamous cell cancer primary located in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than 6 months following the end of the prior RT. Pathology slides from primary as well as recurrence must to be obtained for review by UCI Department of Pathology to confirm histology and patient eligibility. Previous radiation records including simulation and portal films must be submitted to the UCI Department of Radiation Oncology for review of treated areas and to assure that spinal cord tolerance is not exceeded. The recurrence or second primary must have defined bidimensional measurement as follows: All tumor measurements must be recorded in centimeters and should consist of the two longest perpendicular cross-diameters. Patients will be separately assessed for response by physical exam and by CT scan with contrast (unless contraindicated) or MRI scan with T1 contrast with gadolinium (unless contraindicated) and T2 sequences prior to and two months following completion of therapy. Both the clinical (physical exam) and radiographic (CT or MRI) response will be recorded on the study forms. Recurrence or second primary must be confined to the head and neck above the clavicle. The patient must not be a candidate for or refuses complete surgical (re)resection. The majority (>75%) of the tumor volume must have been in areas previously irradiated to >45 Gy. The previous irradiation must not exceed a maximum of 75 Gy. Primary and recurrent cancer treatment cumulative radiation dose must limit total spinal cord dose to 50 Gy. Patients must be at least 1 month from prior chemotherapy and radiation therapy. Karnofsky status 60 or greater. (appendix) WBC >4000/mm3, granulocytes >2,000/mm3, platelets >100,000/mm3, serum bilirubin <1.5 mg/dl, creatinine <1.8 mg/dl within one month from enrollment in protocol. If liver chemistries are above normal limits, a liver ultrasound or CT will be required. Patient must not have a history of other invasive malignancies within the past five years, excluding non-melanomatous skin cancer or cervical cancer in-situ. Exclusion Criteria Distant metastases. History of other invasive malignancies within the past five years excluding non-melanomatous skin cancer or cervical cancer in-situ. Medical condition, which would impede patient tolerance of therapy, completion of therapy or limit survival. Women who are pregnant will be excluded from this trial. A pregnancy test will be offered to women of child bearing age who are otherwise eligible for the protocol. Patients under 18 years of age will be excluded since head and neck cancer is unlikely and due to risk of long term toxicity from radiation including secondary malignancy Patients on any treatment currently for the recurrent head and neck cancer Patients have any untreated infection Patients are candidate for complete surgical resection. Patients have the previous irradiation exceeded a maximum of 75 Gy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nilam Ramshinghani, MD
    Organizational Affiliation
    Chao Family Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer

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