NCT01111942

Brief Summary

This is a non-randomized open-label investigator initiated pilot study comparing follow-up therapy of advanced head and neck cancer subjects initially treated with triple induction chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy based on the subject's apparent clinical response. Spared use of radiation therapy for selective patients who have a complete response to induction chemotherapy could improve well being of this patient population without compromising survival.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for early_phase_1 head-and-neck-cancer

Timeline
Completed

Started Feb 2010

Typical duration for early_phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

3.9 years

First QC Date

April 26, 2010

Last Update Submit

August 4, 2015

Conditions

Head and Neck Cancer

Keywords

head and neck cancerchemotherapyradiation

Outcome Measures

Primary Outcomes (1)

  • Rate of pathologic complete response

    To assess the rate of pathologic complete response of subjects (based on analysis of the surgical specimen), in both the primary site as well as the lymph nodes, with resectable stage III-IV squamous cell carcinoma of the oropharynx treated with TPF induction chemotherapy followed by conservation (organ preservation) surgery for clinically complete responders

    42 months

Secondary Outcomes (6)

  • 2 year overall survival

    42 months

  • Clinical complete response

    42 months

  • 2 year disease-free survival

    42 months

  • Quality of life

    42 months

  • Incidence of HPV and EGFR positivity

    42 months

  • +1 more secondary outcomes

Study Arms (2)

radiation and weekly carboplatin

ACTIVE COMPARATOR
Other: radiation combined with weekly carboplatin

conservation surgery

OTHER
Procedure: conservation surgery

Interventions

radiation combined with weekly carboplatinOTHER

recommended premedications: Aloxi 0.25 mg IV; Dexamethasone 20 mg IV; Fosaprepitant 115 mg IV; Aprepitant 80 mg PO; Ativan 1.0 mg IV; Mucositis treatment should involve local measures to maintain oral hygiene, oral nystatin or fluconazole, or valacyclovir for viral infection. Induction Triple Therapy Treatment with TPF: Docetaxel (Taxotere) 75 mg/m2 IV; Cisplatin (Platinol) 100 mg/m2 IV; 1500 cc Normal Saline w/20meq KCL, 1 gram MgSo4 IV; 5-Fluorouracil (Adrucil) 1000 mg/m2 day IV-continuous infusion over 4 days; Neulasta\* 6 mg SC Day 5 (\*Neupogen may be substituted at the investigator's discretion)

Also known as: Docetaxel, Taxotere, Cisplatin, Platinol, 5-Fluorouracil, Adrucil
radiation and weekly carboplatin
conservation surgeryPROCEDURE

Following induction triple chemotherapy, subjects will be restaged by physical examination and radiological imaging. If there is an absence of unequivocal evidence for residual disease (i.e. an apparent complete response), the subject will undergo conservation surgery under general anesthesia, using a transoral approach. Minimal tissue removal through direct access. The surgical specimen will be evaluated by a pathologist in the manner standard for the institution. The presence of residual tumor will be classified as a partial response to induction triple chemotherapy and the subject will undergo concomitant chemoradiotherapy. If there is no evidence of residual disease in the surgical specimen, the subject will be followed for recurrence.

Also known as: Docetaxel, Taxotere, Cisplatin, Platinol, 5-Fluorouracil, Adrucil
conservation surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Histologically confirmed Stage III-IV (T1, T2, T3) (N0-N2) squamous cell carcinoma of the oropharynx staged according to AJCC guidelines.
  • The subject must be considered surgically resectable via a transoral approach at the time of presentation.
  • Age \>18 years
  • Life expectancy \>/= 5 years
  • ECOG performance status \<2
  • Subject must have measurable disease, at least one lesion accurately measured in at least one dimension as \>10 mm with CT scan.
  • Hematologic Absolute neutrophil count \> 1,000/mm3, Hemoglobin \> 8.0 g/dl Platelet count \> 100,000/mm3 Leukocytes \>3,000/mcL
  • Hepatic Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase within the eligible range
  • Renal - creatinine within normal institutional limits or \>60 mL/min/1.73 m2 creatinine \> institutional normal
  • Women of childbearing potential with negative pregnancy test.
  • Men and women of childbearing age willing to use effective contraception

You may not qualify if:

  • N3 nodal disease according to AJCC guidelines
  • Retropharyngeal nodal involvement
  • Trismus
  • Second primary head and neck tumor unless it is/was a basal or squamous cell skin cancer
  • Prior surgery, chemotherapy, biologic or radiotherapy for a head or neck malignancy
  • Concurrent investigational agent or intervention (within 90 days of screening visit)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxol, cisplatin, 5- fluorouracil, or carboplatin.
  • History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • Breastfeeding women
  • Pre-existing peripheral neuropathy grade \> 3
  • Evidence of distant metastatic disease
  • Unknown primary site
  • Prior or concurrent malignancies (excluding adequately treated basal or squamous cell skin cancer, in situ cervical cancer, stage I or II cancer from which the subject has been in complete remission for at least 12 months (excluding head and neck), any cancer from which the subject has been cancer free for 5 years)
  • History of allergies to any of the pre-medications.
  • Investigator consideration based upon screening interview and/or procedures
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

Location

Related Publications (5)

  • Robbins KT, Howell SB, Williams JS. Intra-arterial chemotherapy for head and neck cancer: is there a verdict? Cancer. 2010 May 1;116(9):2068-70. doi: 10.1002/cncr.24930. No abstract available.

    PMID: 20186833BACKGROUND

  • Malone J, Robbins KT. Neck dissection after chemoradiation for carcinoma of the upper aerodigestive tract: indications and complications. Curr Opin Otolaryngol Head Neck Surg. 2010 Apr;18(2):89-94. doi: 10.1097/MOO.0b013e32833693e7.

    PMID: 20125024BACKGROUND

  • Malone JP, Gerberi MA, Vasireddy S, Hughes LF, Rao K, Shevlin B, Kuhn M, Collette D, Tennenhouse J, Robbins KT. Early prediction of response to chemoradiotherapy for head and neck cancer: reliability of restaging with combined positron emission tomography and computed tomography. Arch Otolaryngol Head Neck Surg. 2009 Nov;135(11):1119-25. doi: 10.1001/archoto.2009.152.

    PMID: 19917925BACKGROUND

  • Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.

    PMID: 19360748BACKGROUND

  • Robbins KT, Homma A. Intra-arterial chemotherapy for head and neck cancer: experiences from three continents. Surg Oncol Clin N Am. 2008 Oct;17(4):919-33, xi. doi: 10.1016/j.soc.2008.04.015.

    PMID: 18722926BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

DocetaxelCisplatinFluorouracilBloodless Medical and Surgical Procedures

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsSurgical Procedures, OperativeHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • K. T. Robbins, M.D.

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Krishna Rao, M.D., Ph.D.

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(1)