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

Primary Purpose

Locally Advanced Head and Neck Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hypofractionated dose escalated VMAT

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Cancer focused on measuring Hypofractionation, VMAT, head and neck cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypofractionated dose escalated VMAT

Conventional concurrent chemoradiation

Arm Description

Hypofractionated dose escalated VMAT radiotherapy

Conventional concurrent chemoradiation

Outcomes

Primary Outcome Measures

Local control in the two arms

Local control by RECIST criteria

Secondary Outcome Measures

The progression free survival in the two arms

The time (in months) from the end of radiotherapy to the date of first progression

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

The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0

Full Information

NCT ID

NCT03699969

First Posted

October 5, 2018

Last Updated

October 9, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03699969

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

October 1, 2018 (Actual)

Study Completion Date

October 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Head and Neck Cancer

Keywords

Hypofractionation, VMAT, head and neck cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated dose escalated VMAT

Arm Type

Experimental

Arm Description

Hypofractionated dose escalated VMAT radiotherapy

Arm Title

Conventional concurrent chemoradiation

Arm Type

No Intervention

Arm Description

Conventional concurrent chemoradiation

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated dose escalated VMAT

Intervention Description

measure the local control, progression free survival and overall survival

Primary Outcome Measure Information:

Title

Local control in the two arms

Description

Local control by RECIST criteria

Time Frame

33 months

Secondary Outcome Measure Information:

Title

The progression free survival in the two arms

Description

The time (in months) from the end of radiotherapy to the date of first progression

Time Frame

33 months

Title

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

Description

The number of patients who develop radiotherapy toxicity as assessed by CTCAE protocol Version 4.0

Time Frame

33 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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