Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

Virginia Commonwealth University (VCU)

Status and phase

Terminated

Phase 1

Conditions

Stage IV Squamous Cell Carcinoma of the Hypopharynx

Stage IV Salivary Gland Cancer

Stage IV Verrucous Carcinoma of the Oral Cavity

Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage III Verrucous Carcinoma of the Oral Cavity

Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage IV Squamous Cell Carcinoma of the Oropharynx

Stage II Squamous Cell Carcinoma of the Hypopharynx

Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

Stage II Squamous Cell Carcinoma of the Oropharynx

Stage III Squamous Cell Carcinoma of the Oropharynx

Salivary Gland Squamous Cell Carcinoma

Stage III Salivary Gland Cancer

Stage II Salivary Gland Cancer

Stage II Verrucous Carcinoma of the Oral Cavity

Stage III Squamous Cell Carcinoma of the Hypopharynx

Treatments

Procedure: positron emission tomography/computed tomography

Other: 3'-deoxy-3'-[18F]fluorothymidine

Drug: cisplatin

Radiation: image-guided adaptive radiation therapy

Radiation: intensity-modulated radiation therapy

Radiation: fludeoxyglucose F 18

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01283178

P30CA016059 (U.S. NIH Grant/Contract)

MCC 13222

NCI-2010-02340 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer

Full description

PRIMARY OBJECTIVES:

I. To determine the feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer.

II. To determine within a predefined range the maximum tolerated radiation dose for concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer.

SECONDARY OBJECTIVES I. To compare gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT before, during, and following completion of chemo-radiation therapy.

II. To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake prior to and during radiation therapy using post-treatment FDG images as an early surrogate for sub-volume-specific local control.

III. To develop a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research. Potential applications include determination of optimal adaptive re-planning frequency and the benefits of basing IGART on 4D anatomic data sets derived from deformably registering daily CBCT and FBCT data sets.

IV. Determine patient long-term toxicities and survival. V. To evaluate the impact of daily image-guided setup; off-line every other week adaptive re-planning; and molecular-image based targeting on sparing of tissues and organs responsible for late and early treatment sequelae.

OUTLINE: This a dose-escalation study of intensity-modulated radiotherapy.

Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 and 4 weeks, 2, 3, 4, 5, 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.

Enrollment

3 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
Locally advanced HN SCC, stages III, IV, and bulky (> 27 cm^3 volume) stage II, excluding larynx and nasopharynx, of no more than 150 cm^3 volume base on CT scan
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Candidate for chemotherapy
Zubrod performance score of 0 or 1
Absolute granulocyte count (AGC) >= 2000 cells/mm^3
Platelet count >= 100,000 cells/mm^3
Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study
Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50 ml/min
Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential

Exclusion criteria

Prior invasive malignancy except non-melanomatous skin cancers unless patient has been disease free for at least 3 years
Prior cancer treatment for this cancer, including gross total tumor excision
Prior radiation treatment to the HN region
Patients with known syndromes that alter radiosensitivity
Any medical contraindications for chemotherapy
Pregnant or lactating women
Women (of childbearing potential) and men who are sexually active and are not willing/able to use a medically acceptable form of contraception throughout the treatment and 60 days thereafter