Adaptive Radiation Therapy for Head & Neck Cancer Patients (IGRT)

Beth Israel Lahey Health

Status: Completed

Conditions: Cancer of Head and Neck

Treatments: Radiation: concurrent chemo + IGRT; Radiation: neoadjuvant chemo + IGRT

Study type: Interventional

Funder types: Other

Identifiers

NCT01853670

167-08

Details and patient eligibility

About

The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.

Full description

The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2

• Patients should meet at least one of the following criteria:

  1. Locally advanced cancer (T3-T4 and/or N2-N3)
  2. Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
  3. Significant expected weight loss.

Exclusion criteria

• Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
• Poor renal function (inability to undergo a CT with IV contrast)
• Previous radiation therapy to the head and neck.
• Inability to tolerate prolonged immobilization.
• Children and women who are pregnant or decline to use contraception.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

definitive radiation + concomitant chemo

Experimental group

Description:

Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment

Treatment:

Radiation: concurrent chemo + IGRT

neoadjuvant chemo

Experimental group

Description:

Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.

Treatment:

Radiation: neoadjuvant chemo + IGRT