AzTrials
AzTrials

Previously-IrradiatedPhase 2NCT02057107

SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN

A Phase 2 study testing SBRT, Cetuximab and Docetaxel in people with Previously-Irradiated and Squamous Cell Carcinoma of the Head and Neck Cancer, run by Heath Skinner at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine before assigning… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBRT, Cetuximab and Docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
3 Jul 2013to 31 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically-proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence but is not mandated per study. This will be at the discretion of the principal investigator.
  • Prior radiation dose of at least 50 Gy.
  • Disease confined to locoregional site and can be encompassed in a stereotactic body radiosurgery "portal"
  • Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.
  • Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high-risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion.
  • Karnofsky performance status > 60 (ECOG 0-1)
Show all 15Show fewer
  • Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy
  • Any number of prior chemotherapy regimens are allowed
  • Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)
  • Age > 18
  • Estimated life expectancy > 12 weeks
  • No prior radiation therapy or chemotherapy within 1 month of study enrollment
  • ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)
  • Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)
  • Ability to provide written informed consent

Who cannot join

  • Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
  • Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
  • Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
  • Concurrent serious infection
  • History of known hypersensitivity to cetuximab, docetaxel or similar agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Center - Radiation Oncology

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine before assigning treatment to either cetuximab and SBRT only or cetuximab, SBRT, and docetaxel.

Read the detailed description

The aim of this trial is to examine the addition of docetaxel on the overall survival of patients otherwise treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).

Being tested
SBRT, Cetuximab, Docetaxel
Keywords
Stereotactic Body Radiation Therapy (SBRT)
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • SBRTRadiation

    Also called Radiosurgery, Stereotactic radiosurgery, CyberKnife, True Beam

    8.8-10 Gy per fraction (total: 44-50 Gy)

  • CetuximabDrug

    Also called Erbitux

    Day -7 (One week prior to commencement of stereotactic radiosurgery):

    Cetuximab, 400 mg/m2

    Days 0 and 8 (The 1st and 2nd week of radiosurgery):

    Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)

  • DocetaxelDrug

    Also called Taxotere

    Days 0 and 8 (The 1st and 2nd week of radiosurgery) Docetaxel, 25 mg/m2 Docetaxel, 25 mg/m2 will be given weekly (following radiosurgery)

Study groups in NCT02057107
Study groupRoleWhat they receive
SBRT + Cetuximab + Docetaxel followed by Cetuximab + DocetaxelOtherPreviously Treated With Cetuximab - Group A; No Previous Cetuximab - Group C
Receives: Radiation: SBRT; Drug: Cetuximab; Drug: Docetaxel
SBRT + Cetuximab followed by CetuximabOtherPreviously Treated with Cetuximab - Group B; No Previous Cetuximab - Group D
Receives: Radiation: SBRT; Drug: Cetuximab

What is being measured

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

  1. 1-Year Locoregional Progression-free survival (PFS)

    The proportion of previously-irradiated patients treated with SBRT, cetuximab, and/or docetaxel, evaluated by PET/CT per RECIST Criteria v1.1 that do not experience locoregional disease progression within one year. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

    Measured: Up to 12 months

  2. Incidence of distant disease

    The proportion of patients with distant disease evaluated by PET/CT or CT per RECIST Criteria v1.1. Malignant disease that has spread to other organs or to lymph nodes other than those near the primary tumor. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

    Measured: Up to 12 months

  3. Acute toxicities

    Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria.

    Measured: Up to 3 months after SBRT treatment

  4. Late toxicities

    Adverse Events and Serious Adverse Events determined by patient follow up per CTCAE v4.0 criteria.

    Measured: From 3 months after SBRT treatment, up to 3 years

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Incidence of either a confirmed Complete Response (CR) or Partial Response (PR), per RECIST Criteria v1.1. Per RECIST, CR is defined as the disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

    Measured: Up to 12 months

  2. Overall Survival (OS)

    Time from the date of randomization to the date of death due to any cause.

    Measured: Up to 5 years

  3. University of Washington QOL Assessment Tool (UW-QOL)

    The UW-QOL is a patient-reported outcome measure consisting of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them. There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL.

    Measured: Up to 5 years

  4. Progression-free Survival (PFS)

    Time from the date of entry on study to the date of progression per RECIST Criteria v1.1 or the date of death from any cause. Subjects who are alive and have not progressed will be censored at their last follow-up date. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

    Measured: Up to 5 years

Timeline

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

  1. First posted6 Feb 2014 (estimated)
  2. Study start3 Jul 2013
  3. Primary completion15 Mar 2019
  4. Study completion31 Dec 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057107
Sponsor's protocol ID
HCC 11-112
Status last verified
Jun 2023
First submitted
30 Jan 2014
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT, Cetuximab and Docetaxel in people with Previously-Irradiated and Squamous Cell Carcinoma of the Head and Neck Cancer, run by Heath Skinner at 1 site 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 15 inclusion and 5 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

1-Year Locoregional Progression-free survival (PFS) (time frame: Up to 12 months). The study lists 4 primary outcomes in all. 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 NCT02057107.

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 5 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in