Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck

NCT02201355 | Terminated Phase 1 DMC

• 1 other identifier: STU 112013-007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives: To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT Secondary Objectives: To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation. To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation. To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation. If patients can safely be treated in three weeks rather than six weeks, such a schedule would provide a much more convenient alternative for patients and result in a significant reduction in the health care resources currently expended on cure of these patients.

Conditions

Squamous Cell Carcinoma of the Head and Neck T1/2N0-2

Keywords

Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• Treatment completion

  To determine whether patients with locally advanced SCC of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT.

  3 weeks

Secondary Outcomes (3)

• adverse events

  90 days

• progression-free survival rates

  5 years

• Health-related quality of life

  2 years

Study Arms (1)

chemoradiation

EXPERIMENTAL

Hypofractionated, PET-directed, Intensity Modulated Radiotherapy Concurrent with Weekly Cisplatin Chemotherapy

Radiation: Intensity Modulated Radiotherapy

Interventions

Intensity Modulated Radiotherapy RADIATION

Patients treated five fractions per week with radiotherapy dose per fraction and cisplatin dose increased according to the treatment table

Also known as: Hypofractionated,

chemoradiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T1/2N0-2M0 SCC of the oropharynx, hypopharynx or larynx
• Age ≥ 18 years.
• Performance status ECOG 0-1
• Adequate organ and marrow function as determined by medical oncology evaluation.
• 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, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• \. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.
• \. Creatinine clearance (CC) ≥ 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\]/\[(Serum Cr mg/dl) x (72)\] (CCr female = 0.85 x (CrCl male)).
• \. History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months.
• \. Medical oncology examination to evaluate medical contraindications prior to start chemotherapy 11 Dental evaluation with management prior to start of radiation 12 Nutrition evaluation with consideration of percutaneous endoscopic gastrostomy (PEG) tube placement 13 No distant metastasis by PET/CT

You may not qualify if:

• T3/4 or N3
• T1N0 disease
• Metastatic disease
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands
• Neck adenopathy that involves the overlying skin.
• Initial surgical treatment including tonsillectomy or neck dissection, but excluding diagnostic biopsy of the primary site or nodal sampling of neck disease
• Pre-existing grade \> 2 peripheral sensory neuropathy
• Subjects may not be receiving any other investigational agents.
• 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.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas at Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Dose Fractionation, Radiation; Radiotherapy Dosage

Study Officials

• Lucien Nedzi, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 28, 2014
• Study Start: September 18, 2014
• Primary Completion: January 23, 2018
• Study Completion: May 15, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

US (1)