Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery

NCT01612351 | Completed Phase 2 Results DMC

• 1 other identifier: LCCC1125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck

Keywords

Head and neck cancer; Squamous Cell Carcinoma; Phase II; Transoral Surgery; Induction Chemotherapy; Carboplatin; Paclitaxel; Lapatinib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  11 weeks

Secondary Outcomes (11)

• Feasibility of 3 Part Therapy

  2 years

• Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.

  11 weeks

• Overall Survival

  up to 7.25 years

• Progression-Free Survival

  Up to 7.25 years

• Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)

  Pre-treatment up to 1 year post surgery

Study Arms (1)

Non-Randomized Single-Arm

EXPERIMENTAL

All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Lapatinib; Drug: Cisplatin; Radiation: Ipsilateral Radiation; Radiation: Bilateral Radiation; Procedure: Transoral Surgery

Interventions

Carboplatin DRUG

Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.

Also known as: Paraplatin

Non-Randomized Single-Arm

Paclitaxel DRUG

Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.

Also known as: Taxol

Non-Randomized Single-Arm

Lapatinib DRUG

Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.

Also known as: Tykerb

Non-Randomized Single-Arm

Cisplatin DRUG

Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.

Also known as: Platinol

Non-Randomized Single-Arm

Ipsilateral Radiation RADIATION

After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.

Also known as: Radiation therapy

Non-Randomized Single-Arm

Bilateral Radiation RADIATION

After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.

Also known as: Radiation therapy

Non-Randomized Single-Arm

Transoral Surgery PROCEDURE

Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.

Also known as: Surgery

Non-Randomized Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated, histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, or supraglottic larynx, and amenable to transoral approach
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix C)
• Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)
• Age ≥18 years
• Adequate bone marrow function as demonstrated by: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hgb \> 10 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable); Platelet count ≥ 100,000/mm3
• Adequate hepatic and renal function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Total serum bilirubin ≤1.5 mg/dL; Creatinine clearance (CrCL) ≥ 40ml/min as measured via Cockcroft-Gault
• Left ventricular ejection fraction (LVEF) must be \> the lower limit of normal (LLN) per institutional standards by either echocardiography or radionuclide-based multiple gated acquisition (MUGA)
• Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
• All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
• Signed an institutional review board (IRB)-approved informed consent document for this protocol.

You may not qualify if:

• tumor 1-node 0 (T1N0) disease or tumor 2-node 0 (T2N0) disease
• Any metastatic disease
• Not considered eligible for any of the chemotherapy agents included in the induction regimen.
• Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
• Major surgery within 3 weeks prior to day 1 of study treatment from which the patient has not completely recovered
• Current use of a prohibited medication or requires any of these medications during treatment with lapatinib prior to study entry
• Receiving any investigational agent currently, or within 2 weeks of Day 1 of treatment on this study
• Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry
• Adequate swallowing function or gastric-tube for drug administration. Of note, lapatinib can be administered via G-tube in a slurry for patients who cannot swallow
• Other prior or concomitant malignancies with the exception of: Non-melanoma skin cancer; In-situ malignancy; Low-risk prostate cancer after curative therapy; Other cancer for which the patient has been disease free for ≥ 3 years
• Pregnant or lactating women, or adults of reproductive potential who do not agree to use adequate contraception during study treatment (see definition of adequate contraception

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

Carboplatin; Paclitaxel; Lapatinib; Cisplatin; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Jared Weiss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: May 19, 2025
• Last Updated: March 17, 2026
• Results First Posted: October 13, 2017

Record last verified: 2026-02

Locations

US (1)