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

Susanne Arnold

Status and phase: Completed; Phase 2

Conditions: Larynx; Head and Neck Cancer

Treatments: Drug: Docetaxel and Carboplatin AUC 6; Radiation: Low dose fractionated radiation - 80cGy with chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02126969

MCC-13-HN-24

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• OR

  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.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Chemotherapy plus Radiation Therapy

Experimental group

Description:

Low dose fractionated radiation - 80cGy with chemotherapy

Treatment:

Radiation: Low dose fractionated radiation - 80cGy with chemotherapy

Chemotherapy without Radiation

Active Comparator group

Description:

Chemotherapy only

Treatment:

Drug: Docetaxel and Carboplatin AUC 6