A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer

NCT03699969 | Unknown

• 1 other identifier: HN12016
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer

Conditions

Locally Advanced Head and Neck Cancer

Keywords

Hypofractionation; VMAT; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Local control in the two arms

  Local control by RECIST criteria

  33 months

Secondary Outcomes (2)

• The progression free survival in the two arms

  33 months

• The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms

  33 months

Study Arms (2)

Hypofractionated dose escalated VMAT

EXPERIMENTAL

Hypofractionated dose escalated VMAT radiotherapy

Radiation: Hypofractionated dose escalated VMAT

Conventional concurrent chemoradiation

NO INTERVENTION

Conventional concurrent chemoradiation

Interventions

Hypofractionated dose escalated VMAT RADIATION

measure the local control, progression free survival and overall survival

Hypofractionated dose escalated VMAT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤70 years old.
• Histopathologically confirmed squamous cell carcinoma of head and neck.
• Locally advanced tumors (T3-T4 \&/or N1-3) (stage IIB, III and stage IV-A: Staging by AJCC 7th edition).
• Patients not exposed to radical surgery for current disease.
• Performance status (ECOG) 2 or less.
• No associated co-morbidity with contraindication to chemotherapy.
• Normal Hemogram. (ANC ≥1.5x109/L, Platelets count ≥100x109/L, hemoglobin ≥80 g/L)
• Accepted renal functions. (BUN \& serum creatinine \<1.5x upper limit of normal value with normal GFR).
• Accepted liver functions. (total bilirubin and direct bilirubin \< 1.5 x ULN \& alanine aminotransferase and aspartate aminotransferase \< 3 x ULN)
• Informed consent.

You may not qualify if:

• Patients with distant metastatic lesions, as detected by imaging techniques.
• Patients with history of other head and neck malignancies.
• Patients with history of previous head and neck irradiation.
• Patients with a serious concomitant illness, such as active cardiac disease, severe uncontrolled hypertension, or uncontrolled infection.
• Women who are pregnant or breast feeding.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 15, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share