Status:
TERMINATED
Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Squamous Cell Carcinoma of the Head and Neck T1/2N0-2
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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 us...
Detailed Description
Head and neck squamous cell carcinomas (HNSCC) are frequently occurring tumors with more than 500,000 new cases worldwide and 45,000 in the USA yearly . Most patients present with local-regionally adv...
Eligibility Criteria
Inclusion
- 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.
- 6\. 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).
- 7 Ability to understand and the willingness to sign a written informed consent.
- 8\. 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)).
- 9\. History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months.
- 10\. 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02201355
Start Date
September 18 2014
End Date
May 15 2020
Last Update
February 2 2021
Active Locations (1)
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1
University of Texas at Southwestern Medical Center
Dallas, Texas, United States, 75390