Status:
WITHDRAWN
Intensity-Modulated Radiotherapy for Recurrent Head and Neck Cancer
Lead Sponsor:
Nilam Ramsinghani
Conditions:
Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00257335
Start Date
October 14 2004
End Date
June 12 2007
Last Update
July 31 2017
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