Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer

NCT05648461 | Unknown

• 1 other identifier: The Accelerate Trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Severe late toxicity grade 3) at 2 year

  Severe late toxicity \> 3 or higher grade 3) at 2 year

  2 years

Secondary Outcomes (9)

• Loco-regional control rate

  2 years

• Disease free survival

  2 years

• Overall Survival

  2 years

• Regional recurrence at ipsilateral level IV

  2 years

• Acute toxicity

  Every week for first month

Study Arms (1)

Five fraction of post operative Radiotherapy

EXPERIMENTAL

The present study is a non -randomised 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.

Radiation: Five fraction of post operative radiotherapy

Interventions

Five fraction of post operative radiotherapy RADIATION

Target volume will include tumor bed \& ipsilateral level I-III levels.

Five fraction of post operative Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above and less than 80 years.
• Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4.
• Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature.
• Pathological N0 neck requiring ipsilateral neck PORT.
• Karnofsky performance score greater or equal 70.
• 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).
• Written informed consent for treatment.
• Available to attend long term follow- up.

You may not qualify if:

• Pathologically positive neck disease.
• Positive margin.
• Patients requiring bilateral neck RT.
• Patients that require re-irradiation for recurrent disease.
• Previous radiotherapy to the head and neck region.
• Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
• Age \< 18 years or \> 80 years.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Nci, Aiims-Jhajjar

Jhajjar, Haryana, 124105, India

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Aman Sharma, MD

CONTACT

+91117018529339; amans757@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aman Sharma

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 13, 2022
• Study Start: March 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 1, 2026
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)