Head and Neck Cancer Clinical Trial
— AccelerateOfficial title:
The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers. The present study is a non -randomized phase II study that will enroll 50 patients and test feasibility of 30 Gy in 5 fractions of the primary disease and ipsilateral level I-III disease.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | February 1, 2026 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Aged 18 or above and less than 80 years. 2. Patient with high risk features: close (= 5mm) margin, presence of LVI or PNI, pT3-4. 3. Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature. 4. Pathological N0 neck requiring ipsilateral neck PORT. 5. Karnofsky performance score greater or equal 70. 6. Timely delivery of PORT preferable within 6-12 weeks of surgery (additional delay of 1-3 weeks of delay beyond 12 weeks is permissible to accommodate for delayed wound healing or other logistics). 7. Written informed consent for treatment. 8. Available to attend long term follow- up. Exclusion Criteria: 1. Pathologically positive neck disease. 2. Positive margin. 3. Patients requiring bilateral neck RT. 4. Patients that require re-irradiation for recurrent disease. 5. Previous radiotherapy to the head and neck region. 6. Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ). 7. Age < 18 years or > 80 years. |
Country | Name | City | State |
---|---|---|---|
India | Nci, Aiims-Jhajjar | Jhajjar | Haryana |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severe late toxicity grade 3) at 2 year | Severe late toxicity > 3 or higher grade 3) at 2 year | 2 years | |
Secondary | Loco-regional control rate | Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months | 2 years | |
Secondary | Disease free survival | Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months] | 2 years | |
Secondary | Overall Survival | Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months] | 2 years | |
Secondary | Regional recurrence at ipsilateral level IV | Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months] | 2 years | |
Secondary | Acute toxicity | RTOG scale | Every week for first month | |
Secondary | Late toxicity | RTOG scale [longitudinal assessment at 3, 6, 12, 18 and 24 months] | 2 years | |
Secondary | Swallowing function | MD Anderson Dysphagia Inventory [longitudinal assessment at 3, 6, 12, 18 and 24 months] | 2 years | |
Secondary | Quality of life EORTC QLQC30 | EORTC QLQC30 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. |
2 years | |
Secondary | Quality of life H&B35 | EORTC H&B35 module [longitudinal assessment at 3, 6, 12, 18 and 24 months]
The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30. |
2 years |
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