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A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma of the Head and Neck

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Trial Information

A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer

Inclusion Criteria:

1. 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.

2. 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

3. Recurrence or second primary must be confined to the head and neck above the

4. The patient must not be a candidate for or refuses complete surgical (re)resection.

5. 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.

6. Primary and recurrent cancer treatment cumulative radiation dose must limit total
spinal cord dose to 50 Gy.

7. Patients must be at least 1 month from prior chemotherapy and radiation therapy.

8. Karnofsky status 60 or greater. (appendix)

9. 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.

10. If liver chemistries are above normal limits, a liver ultrasound or CT will be

11. 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

1. Distant metastases.

2. History of other invasive malignancies within the past five years excluding
non-melanomatous skin cancer or cervical cancer in-situ.

3. Medical condition, which would impede patient tolerance of therapy, completion of
therapy or limit survival.

4. 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.

5. 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

6. Patients on any treatment currently for the recurrent head and neck cancer

7. Patients have any untreated infection

8. Patients are candidate for complete surgical resection.

9. Patients have the previous irradiation exceeded a maximum of 75 Gy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify acute and late toxicities and esponse rates

Principal Investigator

Nilam Ramshinghani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

UCI 03-58



Start Date:

October 2004

Completion Date:

Related Keywords:

  • Carcinoma of the Head and Neck
  • Carcinoma of the head and neck
  • Carcinoma
  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell