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Squamous Cell Carcinoma of the Head and NeckNCT03880396

Definitive Concurrent Hypofractionated Rth With Weekly Cisplatin in Locally Advanced SCCHN

An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
hypofractionated Rth with platinol
Type of treatment
Surgery or procedure
How many people
62 participants
Where
1 siteEgypt
Study dates
10 Mar 2019to 26 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • Active concomitant malignancy;
  • Pregnant and or lactating women;
  • Pre-existing motor or sensory neurotoxicity > CTCAE grade 2.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university

    Asyut, +2

Other trials in Egypt

About this study

Official title: 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.

Read the 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).

Being tested
hypofractionated Rth with platinol
Keywords
chemoradiation, IMRT, Head and neck cancer
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hypofractionated Rth with platinolRadiation

    hypofractionated Rth with weekly cisplatin 40mg/m2

Study groups in NCT03880396
Study groupRoleWhat they receive
hypofractionated Rth with weekly cisplatin 40mg/m2hypofractionated radioyherapy with weekly cisplatin 40mg/m2
Receives: Radiation: hypofractionated Rth with platinol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients havingdegrees of Number of patients having acute toxicities of hypofractionated radiotherapy ,Number of patients with locoregional recurrence-free interval

    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.

    Measured: 2 years

Secondary outcomes (2)

  1. number of patients having degrees of late toxicities of chemoradiation, disease free survival interval,overall survival interval

    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.

    Measured: 2 years

  2. Disease free survival, overall survival, locoregional control

    to detect the 2y-DFS,2y-OS,

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start10 Mar 2019
  3. Primary completion26 Dec 2020
  4. Study completion26 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03880396
Sponsor's protocol ID
chemoradiation in SCCHN
Status last verified
Jul 2022
First submitted
6 Jul 2018
Last updated
26 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thomson DJ, Ho KF, Ashcroft L, Denton K, Betts G, Mais KL, Garcez K, Yap BK, Lee LW, Sykes AJ, Rowbottom CG, Slevin NJ. Dose intensified hypofractionated intensity-modulated radiotherapy with synchronous cetuximab for intermediate stage head and neck squamous cell carcinoma. Acta Oncol. 2015 Jan;54(1):88-98. doi: 10.3109/0284186X.2014.958528. Epub 2014 Oct 3.

    PubMed 25279959

  • Szutkowski Z, Kawecki A, Jarzabski A, Laskus Z, Krajewski R, Michalski W, Kukolowicz P. Hypofractionated accelerated radiotherapy in T1-3 N0 cancer of the larynx: A prospective cohort study with historical controls. Rep Pract Oncol Radiother. 2016 Nov-Dec;21(6):537-543. doi: 10.1016/j.rpor.2016.08.001. Epub 2016 Sep 20.

    PubMed 27698593

Questions about this trial

What is this clinical trial studying?

An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03880396, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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