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Head and Neck CancerPhase 2NCT01372111

Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

A Phase 2 study testing Cisplatin and Elective Nodal Irradiation (ENI) in people with Head and Neck Cancer, run by Coastal Carolina Radiation Oncology at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cisplatin and Elective Nodal Irradiation (ENI)
How many people
76 participants
Where
5 sitesUnited States
Study dates
Mar 2011to Mar 2016
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

  • Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
  • No surgical resection of primary site or neck dissection (excisional biopsy of lymph node is permitted)
  • Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by immunohistochemistry
  • Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of the base of tongue and hypopharynx are eligible
  • ECOG performance status 0-1
  • Age >18 years
Show all 13Show fewer
  • No current pregnancy
  • No other invasive malignancies within the last 2 years Patients with basal cell or squamous cell skin cancers or carcinoma in situ of any site are eligible.
  • No prior radiotherapy to the head and neck region
  • No prior cisplatin chemotherapy
  • No symptomatic coronary disease or myocardial infarction within the last 6 months
  • Laboratory evaluation: ANC > 2,000/mm3, platelets >100,000/mm3, creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min, bilirubin < 1.5 mg/dl, AST or ALT < 2X upper normal limit
  • Study-specific consent signed prior to entry

Who cannot join

  • Second primary malignancy that is clinically detectable
  • Inability or unwillingness to comply with chemoRT
  • Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck.
  • Metastatic disease (M1)
  • Pregnant or breast-feeding women.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Coleman Radiation Oncology Center

    Morehead City, North Carolina, 28557

  • CarolinaEast Cancer Care

    New Bern, North Carolina, 28561

  • South Atlantic Radiation Oncology

    Supply, North Carolina, 28462

  • Coastal Carolina Radiation Oncology

    Wilmington, North Carolina, 28401

  • Zimmer Cancer Center

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial

Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.

Being tested
Cisplatin, Elective Nodal Irradiation (ENI)
Keywords
Stg III or IVa Squamous Cell Carcinoma., Advanced
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.

  • CisplatinDrug

    Also called Cis-Diamminedichloroplatinum, DDP

    Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.

  • Elective Nodal Irradiation (ENI)Radiation

    Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.

What is being measured

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

  1. To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.

    Measured: 4 years

Secondary outcomes (3)

  1. To assess actuarial LRC, DFS, and OS rates.

    Measured: 4 years

  2. To evaluate patients' quality of life (QOL).

    Measured: 4 years

  3. To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.

    Measured: 4 years

Timeline

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

  1. First posted13 Jun 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2016 (estimated)

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
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01372111
Sponsor's protocol ID
CCRO11
Other IDs
U54CA142152-02
Status last verified
Dec 2015
First submitted
6 Jun 2011
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Maguire PD, Papagikos M, Hamann S, Neal C, Meyerson M, Hayes N, Ungaro P, Kotz K, Couch M, Pollock H, Tepper J. Phase II trial of hyperfractionated intensity-modulated radiation therapy and concurrent weekly cisplatin for Stage III and IVa head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2011 Mar 15;79(4):1081-8. doi: 10.1016/j.ijrobp.2009.12.046. Epub 2010 Apr 8.

    PubMed 20378262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin and Elective Nodal Irradiation (ENI) in people with Head and Neck Cancer, run by Coastal Carolina Radiation Oncology at 5 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 13 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

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?

To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin. (time frame: 4 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 NCT01372111, which also lists 1 linked publication.

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 9 Dec 2015.

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