Protocol Title:

A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone

Protocol Status:

Closed

Protocol Number:

R 0421

Type of Cancer:

Head and neck cancer, recurrent, previously irradiated

Principal Investigator :

Gopal Bajaj, MD

Research Nurse:

Shirl DiPasquale, RN, MS. OCN

Phase Number:

III

General Eligibility:

Pathologically confirmed diagnosis of recurrent or second
primary squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, or recurrent neck metastases with unknown primary; - Biopsy of primary tumor and/or fine needle aspirate/biopsy of metastatic lymph node is required prior to registration;
- Measurable disease is required;
- Patients must be surgically inoperable. Patients with measurable recurrent disease after attempted surgical resection are eligible if they are = 3 months post-surgery, have completely healed wounds, and meet all other eligibility criteria. Patients must not have any signs of carotid exposure.
- Patients must have had prior radiation for head and neck SCC with > 75% of the present tumor volume in areas that have been previously irradiated to at least 45 Gy but not exceeding 75 Gy;
- Prior radiotherapy data and anatomical location of gross tumor volume such that the Radiation Oncologist will have the ability to successfully re-irradiate without exceeding lifetime spinal cord dose of 54 Gy; this will be based upon physical examination plus a diagnostic and/or radiotherapy treatment planning CT and/or MRI scan done within 8 weeks prior to registration
- The time from prior radiation therapy to first recurrence must be > 6 months; patients may have experienced more than one recurrence as long as the first recurrence occurred > 6 months following the end of the prior radiation treatment;
-At registration, patients must be at least 6 months post-radiation therapy or chemotherapy (or targeted agents, such as EGFR inhibitors);
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination
-and medical oncology and radiation oncology examination to confirm study eligibility requirements within 8 weeks prior to registration;
Chest CT scan within 4 weeks prior to registration; patients with equivocal pulmonary nodules that are < 1 cm, that cannot be safely biopsied, or that are negative on PET imaging are eligible;
- Imaging (CT or MRI) of tumor site within 4 weeks prior to registration;
Treatment must begin within 7-10 days of registration.
- Zubrod Performance Status 0-1;
- Age > 18;
- Adequate bone marrow function and laboratory parameters, defined in protocol
- Abdominal CT, if abnormal LFTs are noted (must be done in presence of > 1.5 x upper limit of normal of alkaline phosphatase, AST, bilirubin, or other clinical indicator);
- Adequate renal function, defined in protocol
- Creatinine clearance > 50 ml/min within 2 weeks prior to registration –
- Serum calcium or corrected serum calcium < 11.5 within 2 weeks prior to registration;

Purpose:

Primary Objective
To determine whether re-irradiation plus concurrent chemotherapy improves overall survival of patients with previously irradiated, non-metastatic, locally recurrent or new primary squamous cell
carcinoma of the head and neck (SCCHN) as compared to conventional chemotherapy alone

Secondary Objectives
-To compare the progression-free survival (PFS) between the two approaches
- To assess the toxicity of each treatment regimen
- To evaluate whether differences in patients’ quality of life and functional/performance status are
associated with a treatment program
- To compare the quality adjusted survival between the two approaches

Treatment:

Arm 1: Re-irradiation plus concurrent chemotherapy
Radiation therapy on weeks 1,3,5,and 7 1.5 Gy/fx twice daily x5days, 40 fractions for a total dose of 60 Gy
Chemotherapy (cisplatin/paclitaxel) on weeks 1,3,5,and 7
G-CSF on weeks 2,4,6,and 8

Arm 2: Chemotherapy alone
Select from one of the three standard chemotherapy regimens:
Cisplatin/ 5-FU; cisplatin/paclitaxel; cisplatin/docetaxel