Stage III Squamous Cell Carcinoma of the Lip and Oral CavityNCT02295540
Hypofractionated Radiation Therapy Followed by Surgery in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity
A study testing hypofractionated radiation therapy, intensity-modulated radiation therapy and therapeutic conventional surgery in people with Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity and Stage III Verrucous Carcinoma of the Oral Cavity, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
- What is being tested?
- hypofractionated radiation therapy, intensity-modulated radiation therapy and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Jan 2020
- Phase
- Interventional
- 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
- Patient is willing to sign study specific informed consent
- Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
- Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head \& neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology
- Patient is deemed to be a surgical candidate by ENT
- Karnofsky performance status (KPS) 0-2
- For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
- Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (CD4) count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (HAART) is allowed
- Patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years
Who cannot join
- Metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (PET)/CT or biopsy
- KPS 3 or worse
- Gross disease in the retrostyloid (high level II) or retropharyngeal lymph node regions by CT or PET/CT
- Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
- Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
- Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
- Women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patient is deemed to not be a surgical candidate by ENT
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
New Jersey Medical School
Newark, New Jersey, 07103
About this study
Official title: Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.
Read the detailed description
PRIMARY OBJECTIVES:
- 2 year locoregional control for advanced oral cavity squamous cell carcinoma (SCC) treated with preoperative hypofractionated radiation followed by surgical resection.
SECONDARY OBJECTIVES:
- Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes (LN).
II. Rate of radiologic complete and partial response (computed tomography [CT] neck with intravenous [IV] contrast performed before and after radiation therapy, judged per Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria).
III. Grade III/IV/V toxicity both short term (from start of radiation to 60 days after surgery) and long term (more than 60 days after surgery).
IV. Rate of flap complications: Rate of flap revisions, and complete revisions required.
- Molecular correlates. VI. Quantitative imaging correlates.
OUTLINE:
Patients undergo hypofractionated intensity-modulated radiation therapy (IMRT) every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years.
- Conditions
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Verrucous Carcinoma of the Oral Cavity
- Being tested
- hypofractionated radiation therapy, intensity-modulated radiation therapy, therapeutic conventional surgery, laboratory biomarker analysis
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiation therapyRadiation
Undergo hypofractionated IMRT
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo hypofractionated IMRT
therapeutic conventional surgeryProcedure or surgery
Undergo surgery
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (hypofractionated IMRT, surgery) | Experimental | Patients undergo hypofractionated IMRT every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment. Receives: Radiation: hypofractionated radiation therapy; Radiation: intensity-modulated radiation therapy; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.
Measured: 2 years
Secondary outcomes (8)
Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes
Measured: Up to 2 years
Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria
CT neck with IV contrast will be performed before and after radiation therapy.
Measured: Up to 2 years
Incidence of short term grade III/IV/V toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Interim analysis will be used for grade IV toxicity (death).
Measured: Up to 60 days post-surgery
Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0
Measured: Up to 2 years
Rate of flap complications (rate of flap revisions and flap complete revisions required)
Measured: Up to 2 years
Expression of molecular markers
Will correlate molecular markers (especially those relating to radioresitance such as B-cell lymphoma 2 or autophagy markers to locoregional control).
Measured: Up to 24 hours after initial radiation treatment
Quantitative imaging characteristics in the pre-treatment PET/CT
Includes max/peak/total/mean standard uptake value, the metabolic tumor volume, and the total lesion glycolysis. These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.
Measured: Baseline
Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter
These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.
Measured: Baseline to up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Squamous Cell Carcinoma of the Lip and Oral CavityStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Preoperative hypofractionated radiation followed by surgical resection
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Sung Kim, MD, Residency and Clinical Director, Rutgers Cancer Institute of New Jersey
- Investigators
- Sung Kim, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295540
- Sponsor's protocol ID
- Pro20140000684
- Other IDs
- NCI-2014-02215, 031401, P30CA072720
- Status last verified
- Sep 2022
- First submitted
- 17 Nov 2014
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02295540
- Acronym / sponsor ID
- Pro20140000684
- Conditions
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Verrucous Carcinoma of the Oral Cavity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Aug 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.
Detailed description
PRIMARY OBJECTIVES:
- 2 year locoregional control for advanced oral cavity squamous cell carcinoma (SCC) treated with preoperative hypofractionated radiation followed by surgical resection.
SECONDARY OBJECTIVES:
- Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes (LN).
II. Rate of radiologic complete and partial response (computed tomography [CT] neck with intravenous [IV] contrast performed before and after radiation therapy, judged per Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria).
III. Grade III/IV/V toxicity both short term (from start of radiation to 60 days after surgery) and long term (more than 60 days after surgery).
IV. Rate of flap complications: Rate of flap revisions, and complete revisions required.
- Molecular correlates. VI. Quantitative imaging correlates.
OUTLINE:
Patients undergo hypofractionated intensity-modulated radiation therapy (IMRT) every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Preoperative hypofractionated radiation followed by surgical resection
| Arm | Type | Receives |
|---|---|---|
| Treatment (hypofractionated IMRT, surgery) | Experimental | Radiation: hypofractionated radiation therapy, Radiation: intensity-modulated radiation therapy, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients undergo hypofractionated IMRT every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is willing to sign study specific informed consent
- Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
- Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head \& neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology
- Patient is deemed to be a surgical candidate by ENT
- Karnofsky performance status (KPS) 0-2
Key exclusion criteria (8 listed)
- Metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (PET)/CT or biopsy
- KPS 3 or worse
- Gross disease in the retrostyloid (high level II) or retropharyngeal lymph node regions by CT or PET/CT
- Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
- Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypofractionated radiation therapyUndergo hypofractionated IMRT | Radiation | Treatment (hypofractionated IMRT, surgery) |
| intensity-modulated radiation therapyAlso: IMRTUndergo hypofractionated IMRT | Radiation | Treatment (hypofractionated IMRT, surgery) |
| therapeutic conventional surgeryUndergo surgery | Procedure or surgery | Treatment (hypofractionated IMRT, surgery) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (hypofractionated IMRT, surgery) |
Primary outcome
Locoregional control
Time frame: 2 years
Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.
8 secondary outcomes
Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes
Time frame: Up to 2 years
Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria
Time frame: Up to 2 years
Incidence of short term grade III/IV/V toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Time frame: Up to 60 days post-surgery
Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0
Time frame: Up to 2 years
Rate of flap complications (rate of flap revisions and flap complete revisions required)
Time frame: Up to 2 years
Expression of molecular markers
Time frame: Up to 24 hours after initial radiation treatment
Quantitative imaging characteristics in the pre-treatment PET/CT
Time frame: Baseline
Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter
Time frame: Baseline to up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Kim principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated radiation therapy, intensity-modulated radiation therapy and therapeutic conventional surgery in people with Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity and Stage III Verrucous Carcinoma of the Oral Cavity, run by Rutgers, The State University of New Jersey 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 28 Sep 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Locoregional control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.