A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

NCT02126969 | Completed Phase 2 Results DMC

• 1 other identifier: MCC-13-HN-24
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.

Conditions

Head and Neck Cancer; Larynx

Keywords

Cancer; Low dose radiation

Outcome Measures

Primary Outcomes (1)

• Primary Site Complete Response Rate

  Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.

  Up to 50 days

Secondary Outcomes (3)

• Overall Response Rate

  Up to 50 days

• Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.

  Up to 50 days (pre- and post-treatment)

• 3-year Overall Survival

  From date of randomization until date of death from any cause, assessed up to 3 years

Study Arms (2)

Chemotherapy plus Radiation Therapy

EXPERIMENTAL

Low dose fractionated radiation - 80cGy with chemotherapy

Radiation: Low dose fractionated radiation - 80cGy with chemotherapy

Chemotherapy without Radiation

ACTIVE COMPARATOR

Chemotherapy only

Drug: Docetaxel and Carboplatin AUC 6

Interventions

Low dose fractionated radiation - 80cGy with chemotherapy RADIATION

Chemotherapy + 80 cGy of RT

Chemotherapy plus Radiation Therapy

Docetaxel and Carboplatin AUC 6 DRUG

Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

Chemotherapy without Radiation

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
• Measurable disease.
• ECOG performance status of 0, 1 or 2
• No prior chemotherapy for the current locally advanced SCCHN.
• Age ≥18 years.
• Life expectancy of greater than 3 months
• Normal organ and marrow function measured within 14 days of registration as defined below:
• absolute neutrophil count ≥ 1,000/mcL
• platelets ≥ 100,000/mcL
• total bilirubin \< institutional upper limit of normal
• AST(SGOT ≤ 2.5 × institutional upper limit of normal
• Alkaline phosphatase ≤ 2.5 × institutional upper limit of normal
• creatinine within normal institutional limits
• o Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.

You may not qualify if:

• Prior chemotherapy for SCCHN
• Patients who are receiving any other investigational agents.
• Patients with known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women
• HIV-positive patients on combination antiretroviral therapy
• Other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years.
• Patients with nasopharynx or salivary gland primary site
• Patients with distant metastatic disease (M1c)
• Patients with grade II or greater peripheral neuropathy

Sponsors & Collaborators

• Susanne Arnold: lead

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Laryngeal Diseases; Neoplasms

Interventions

Drug Therapy; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Susanne Arnold
• Organization: University of Kentucky

smarno0@uky.edu

8592579568

Study Officials

• Susanne M Arnold, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 30, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 15, 2021
• Last Updated: March 13, 2023
• Results First Posted: June 20, 2019

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)