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

• ClinicalTrials.gov Identifier: NCT03699969
• Recruitment Status: Unknown
• First Posted: October 9, 2018
• Last Update Posted: October 11, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ehab Saad, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Locally Advanced Head and Neck Cancer	Radiation: Hypofractionated dose escalated VMAT	Not Applicable

Detailed Description:

patients were randomized to receive either: 70Gy in 35fx in 7wks at 2Gy/fx concurrently with weekly cisplatin 40mg/m2 (Arm A) or 74Gy in 33 fractions (fx) in 6.5 weeks at 2.24Gy/fx (Arm B). Volumetric Modulated Arc Therapy (VMAT) plans were created for both treatment arms

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: October 1, 2018
• Estimated Study Completion Date: October 15, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hypofractionated dose escalated VMAT; Hypofractionated dose escalated VMAT radiotherapy	Radiation: Hypofractionated dose escalated VMAT; measure the local control, progression free survival and overall survival
No Intervention: Conventional concurrent chemoradiation; Conventional concurrent chemoradiation

Outcome Measures

Primary Outcome Measures :

1. Local control in the two arms [ Time Frame: 33 months ]
   Local control by RECIST criteria

Secondary Outcome Measures :

1. The progression free survival in the two arms [ Time Frame: 33 months ]
   The time (in months) from the end of radiotherapy to the date of first progression
2. The incidence of toxicity of radiotherapy by CTCAE protocol in the two arms [ Time Frame: 33 months ]
   The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Ehab Saad, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03699969
• Other Study ID Numbers: HN12016
• First Posted: October 9, 2018
• Last Update Posted: October 11, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ehab Saad, Cairo University:

Hypofractionation; VMAT; head and neck cancer

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms