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Head and Neck CancerPhase 2INFIELDNCT03067610

Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer

A Phase 2 study testing Intensity Modulated Radiation Therapy and chemotherapy in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by University of Texas Southwestern Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Intensity Modulated Radiation Therapy and chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesUnited States
Study dates
20 Jan 2017to 9 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx. Squamous cell carcinoma of unknown primary is not allowed.
  • Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Patients may undergo a diagnostic tonsillectomy, and diagnostic lymph node excision (< 2 nodes) is also allowable.
  • Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  • Age ≥ 18 years.
  • ECOG Performance Status 0-2
  • Adequate organ and marrow function as defined below:
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  • leukocytes ≥ 3,000/mcL
  • absolute neutrophil count ≥ 1,500/mcL
  • platelets ≥ 100,000/mcl
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
  • Neck CT and/or neck MRI, and whole body PET-CT.
  • Ability to understand and the willingness to sign a written informed consent.

Who cannot join

  • Distant metastasis or adenopathy below the clavicles.
  • Inability to undergo PET-CT.
  • Stage I and II glottic carcinoma.
  • Gross total excision of both the primary and nodal disease.
  • Synchronous primaries outside of the oropharynx and larynx.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 1 years
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  • Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  • Subjects may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • History of immunosuppression or autoimmunity, including HIV, and organ or stem cell transplant, or an autoimmune condition previously treated with immunosuppressive therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy

Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Read the detailed description

This study aims to significantly improve the acute and late morbidity of patients with oropharyngeal and laryngeal squamous cell carcinoma both by tailoring the elective irradiation only to regions with a legitimate risk of recurrence (> 5%) and by lowering the elective dose to 40 Gy. Level IB will not be electively treated unless it is involved with pathologic or suspicious lymphadenopathy. Level V will not be treated unless two or more ipsilateral nodal levels are involved (or level V itself has pathologic or suspicious adenopathy). Levels III and IV will only be irradiated if the immediately proximal level contains pathologic lymphadenopathy (i.e. level III irradiated if level II is positive; level IV irradiated if level III is positive). We anticipate that this approach should dramatically improve the acute and late complication profile.

Being tested
Intensity Modulated Radiation Therapy, chemotherapy
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell, Mouth Neoplasms, Pharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.

  • chemotherapyDrug

    Also called cisplatin, cetuximab, or carboplatin-paclitaxel

    chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion

Study groups in NCT03067610
Study groupRoleWhat they receive
Radiation TherapyExperimentalIntensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Solitary Elective Volume Recurrence

    The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.

    Measured: 2 years

Secondary outcomes (7)

  1. Quality of Life (QOL) Patient Reported Outcomes (PRO)

    Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI).

    EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms.

    MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.

    Measured: 12 months

  2. Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)

    Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.

    Measured: 2 years

  3. Total Number of Participants With Gastrostomy Dependence

    The prevalence of gastrostomy use up to 2 years will be described.

    Measured: 2 years

  4. Patient Utilities

    The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).

    Measured: 2 years

  5. Overall Survival

    Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.

    Measured: 2 years

  6. Progression-free Survival

    Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression.

    Measured: 2 year

  7. Probability of Locoregional or Distant Tumor Failure

    The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start20 Jan 2017
  3. Primary completion21 Dec 2020
  4. Study completion9 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
radiation therapy
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067610
Sponsor's protocol ID
STU 052016-044
Acronym
INFIELD
Status last verified
Feb 2022
First submitted
18 Nov 2016
Last updated
17 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intensity Modulated Radiation Therapy and chemotherapy in people with Head and Neck Cancer and Carcinoma, Squamous Cell, run by University of Texas Southwestern Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Solitary Elective Volume Recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.

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