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

NCT01283178 | Terminated Phase 1 DMC

• 3 other identifiers: MCC 13222NCI-2010-02340P30CA016059
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salivary Gland Squamous Cell Carcinoma; Stage II Salivary Gland Cancer; Stage II Squamous Cell Carcinoma of the Hypopharynx; Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage II Squamous Cell Carcinoma of the Oropharynx; Stage II Verrucous Carcinoma of the Oral Cavity; Stage III Salivary Gland Cancer; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Verrucous Carcinoma of the Oral Cavity; Stage IV Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Verrucous Carcinoma of the Oral Cavity

Keywords

squamous cell carcinoma of the paranasal sinus and nasal cavity

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (5)

• Comparison of gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT

  Before, during, and following completion of chemoradiation therapy

• Impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake using post-treatment FDG images as an early surrogate for sub-volume-specific local control

  Prior to and during radiation therapy

• Development of a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research

  Up to 5 years

• Patient long-term toxicities and survival

  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

• 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

  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

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Radiation: image-guided adaptive radiation therapy; Other: 3'-deoxy-3'-[18F]fluorothymidine; Procedure: positron emission tomography/computed tomography; Radiation: fludeoxyglucose F 18

Interventions

intensity-modulated radiation therapy RADIATION

Undergo intensity-modulated image-guided adaptive radiotherapy

Also known as: IMRT

Arm I

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Arm I

image-guided adaptive radiation therapy RADIATION

Undergo intensity-modulated image-guided adaptive radiotherapy

Also known as: IGART, image-guided adaptive radiotherapy

Arm I

3'-deoxy-3'-[18F]fluorothymidine OTHER

Undergo FLT-PET scans for IMRT/IGART

Also known as: 18F-FLT

Arm I

positron emission tomography/computed tomography PROCEDURE

Undergo FDG/FLT-PET scans for IMRT/IGARTT

Arm I

fludeoxyglucose F 18 RADIATION

Undergo FDG-PET scans for IMRT/IGART

Also known as: 18FDG, FDG

Arm I

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-Modulated; Cisplatin; alovudine; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Shiyu Song

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)