Definitive Concurrent Hypofractionated Rth With Weekly Cisplatin in Locally Advanced SCCHN

July 22, 2022 updated by: Doaa Gamal Abdelnaser Fathy Mahmoud, Assiut University

Definitive Concurrent Hypofractionated Radiotherapy With Weekly Cisplatin in Locally Advanced Squamous Cell Carcinoma Head and Neck (SCCHN)

The primary endpoint will be acute toxicity. Secondary endpoints included: late toxicity and quality of life; loco-regional control, disease free survival and overall survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Head and neck cancer is considered the 6th most common cancer all over the world, with 890,000 new cases and 450,000 deaths in 2018 (1). The histologic type in more than 90% of head and neck cancer is squamous cell carcinoma (SCC) (2). The incidence of SCC in head and neck (SCCHN) continues to rise and is expected to increase by 30% in 2030, which means about 1.08 million new cases annually (3). Hospital-based studies in Egypt showed that SCCHN represents about 20% of all malignancies. The overall incidence of SCCHN in Egypt from 1999 to 2006 was approximately twice among males (476,000) than in females (273,000) (4). Males are affected significantly more than females, with a ratio ranging from 2:1 to 4:1 (5).

Tobacco and alcohol consumption are the high-risk factors of SCCHN (6). Human papilloma virus (HPV), especially subtypes 16 and 18 are implicated risk factors in oropharyngeal cancer (7). Some studies found an association between HPV and P53 gene mutation, as HPV expresses two viral proteins (E6 and E7 proteins) that inactivates P53 and pRB genes, causing genomic instability and malignant transformation ((8)). SCCHN arises from the mucosal epithelium of the oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx. HPV associated SCCHN arises primarily from the palatine and lingual tonsils of the oropharynx, whereas tobacco associated SCCHN arises primarily in the oral cavity, hypopharynx, and larynx.

SCCHN is being increasingly treated by multimodality approaches combining surgery, radiotherapy (RT), and chemotherapy (CTH). Randomized controlled trials have demonstrated major improvements in loco-regional tumor control (LRC) from altered fractionation RT with CTH as compared with conventional fractionated RT (CFRT) (9). Altered fractionation schedules reduces tumor repopulation effect and seek to improve the therapeutic ratio between tumor cell killing and normal tissue damage. Additionally, some data showed that cancer patients are at higher risk of COVID-19 infection comparing with the general population due to many treatment visits, so hypo-RT schedules are better for these patients. hypo-RT utilizes a small number of fractions with a larger dose per fraction (> 2Gy per fraction), shortening overall treatment time compared to a CFRT (9). Although a shorter treatment time can be obtained by applying a higher dose per fraction, it might also result in an increase in the incidence of late complications.

The aim of this study was to investigate hypo fractionated intensity modulated RT (hypo-IMRT) with 62.5 Gy in 25 daily fractions over five weeks (2.5 Gy per fraction with weekly cisplatin 40mg/m2 in patients with high-risk stage II (T2N0, excluding glottic laryngeal) disease, stage III (T1-3 N1 or T3N0) and stage IV (T1-4N2 orN3). The primary endpoint will be assessment of acute toxicity. Secondary endpoints included: late toxicity and quality of life; LRC, disease free survival (DFS) and overall survival (OS).

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, +2
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A planned 62 patients were recruited in the period from 2018 to 2021, 52(83.9%) were males and the remaining 10 (16.1%) were females. 22 of patients were current smoker. Patients had histologically or cytologically proven oropharyngeal (32.3%), laryngeal (32.3%) or hypopharyngeal squamous cell carcinoma (18.2%); with AJCC high risk stage II (T2N0, excluding glottic laryngeal) disease (22.6%), stage III (T1-3N1 or T3N0) (30.6%) and stage IV (T1-4N2 or N3) (46.8%). Human papilloma virus status was not tested at the time of paper design.

Description

Inclusion Criteria:

  • Have histologically or cytologically proven oropharyngeal, laryngeal or hypopharyngeal squamous cell carcinoma; with AJCC high risk stage II (T2N0, excluding glottic laryngeal) disease, stage III (T1-3N1 or T3N0) and stage IV (T1-4N2 or N3) Locally advanced non metastatic stage II/IV SCCHN according to AJCC stage classification 2018 (8th edition);
  • Age >18 years and <75 years;
  • No previous treatment(neither chemotherapy nor radiotherapy);
  • Eastern Cooperative Oncology Group(ECOG) performance status of <2;
  • Adequate organ function;
  • Provide informed oral or written consent.

Exclusion Criteria:

  • prior surgical curative resection for primary tumor;
  • patients with metastatic disease;
  • prior radiotherapy within the treatment field;
  • any relative contraindication to radiotherapy;
  • prior administration of EGFR monoclonal antibodies, signal transduction inhibitors or targeted therapies;
  • Active severe infection;
  • Active concomitant malignancy;
  • Pregnant and or lactating women;
  • Pre-existing motor or sensory neurotoxicity > CTCAE grade 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hypofractionated Rth with weekly cisplatin 40mg/m2
hypofractionated radioyherapy with weekly cisplatin 40mg/m2
Radiation: hypofractionated Rth with platinol
hypofractionated Rth with weekly cisplatin 40mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients havingdegrees of Number of patients having acute toxicities of hypofractionated radiotherapy ,Number of patients with locoregional recurrence-free interval
Time Frame: 2 years
degree of acute toxicity (mucosititis degree) according to RECIST criteria,degree of dysphagia ,Number of patients with locoregional recurrence-free interval This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients having degrees of late toxicities of chemoradiation, disease free survival interval,overall survival interval
Time Frame: 2 years
number of patients having late toxicity (grade's of xerostomia, dysphagia), disease free survival, overall survival accordind to RECIST criteria This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as disease-free survival as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
2 years
Disease free survival, overall survival, locoregional control
Time Frame: 2 year
to detect the 2y-DFS,2y-OS,
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Doaa G Abdelnaser Fathy Mahmoud, Doctor, Assiut University
  • Principal Investigator: Hoda H Essa, Doctor, Assiut University
  • Principal Investigator: Aiat M Mohammed, Doctor, Assiut University
  • Principal Investigator: Mohamed O Gad, Doctor, Assiut University
  • Principal Investigator: Nora Essam, South Egypt Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2019

Primary Completion (Actual)

December 26, 2020

Study Completion (Actual)

December 26, 2020

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chemoradiation in SCCHN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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