Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

NCT03164460 | Suspended Phase 2 DMC

• 2 other identifiers: 2016-1065NCI-2018-01190
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

Conditions

Recurrent Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)

  Will use the methods of Gooley et al. to estimate the cumulative incidence of Tox3+, as well as competing-risk regression to model cumulative incidence of Tox3+ while treating death not related to Tox3+ as a competing event. The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.

  At 2 years

Secondary Outcomes (7)

• Local control defined as absence of local failure

  Up to 2 years

• Local failure free survival (LFFS) defined as failure (recurrence or progression) within the prescribed radiation field, including failure within 2 cm of the radiation field

  From treatment initiation until local failure or death from any cause, assessed at 2 years

• Incidence of acute grade 3 or higher toxicity assessed by CTCAE

  Up to 90 days after completion of radiation therapy

• Incidence of late grade 3 or higher toxicity assessed by CTCAE

  90 days up to 2 years

• Progression free survival (PFS)

  From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years

Study Arms (2)

Group I (SBRT)

EXPERIMENTAL

Patients undergo SBRT every other day for a total of 5 treatments.

Radiation: Stereotactic Body Radiation Therapy

Group II (IMRT/IMPT)

EXPERIMENTAL

Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

Radiation: Intensity-Modulated Radiation Therapy; Radiation: Proton Radiation

Interventions

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT/IMPT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Group II (IMRT/IMPT)

Proton Radiation RADIATION

Undergo IMRT/IMPT

Also known as: Radiation, Charged Particles-Protons

Group II (IMRT/IMPT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Group I (SBRT)

Eligibility Criteria

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

You may qualify if:

• Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
• Not eligible for surgery for recurrence or poor surgical candidate
• Gross disease apparent on imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\])
• sites of recurrence (\< 60 cc per site, total volume \< 100 cc)
• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
• Negative pregnancy test for women of child bearing potential

You may not qualify if:

• Patients who are pregnant or breast feeding
• Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
• a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
• b) No myocardial infarction within 3 months of registration
• Widely metastatic disease (oligometastatic disease acceptable)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated; Proton Therapy; Radiation; Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Heavy Ion Radiotherapy; Physical Phenomena; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jack Phan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: May 22, 2017
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-02

Locations

US (1)