An Experimental Study to Compare Treatment Response and Toxicities of Concurrent Chemoradiation With Weekly Cisplatin and Three Weekly Cisplatin in Locally Advanced Head and Neck Cancer.

Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03998696

Acronym

HNC

Enrollment

Registered

2019-06-26

Start date

2017-07-01

Completion date

2018-12-31

Last updated

2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy

Brief summary

The aim of this study is to compare treatment responses and toxicities of concurrent chemo-radiation with weekly and three weekly Cisplatin in locally advanced Head & Neck Cancer. Half of the participants received Cisplatin (40 mg/m2) weekly with radiotherapy, while the other half received Cisplatin (100 mg/m2) thrice weekly with radiotherapy. Radiotherapy continued five days per week for six and half weeks.

Interventions

DRUGCisplatin 40 mg/m2

Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy

DRUGCisplatin 100 mg/m2

Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Biopsy proved, previously untreated, Squamous cell carcinoma of head & neck * Stages III to IVB

Exclusion criteria

* Patients with history of prior chemotherapy or radiotherapy to the head and neck region. * Initial surgery (excluding diagnostic biopsy) of the primary site. * Patients with synchronous primaries. * Those who are not willing to be included in the study. * Pregnant or lactating woman. * Serious medical illness * Prisoners.

Design outcomes

Primary

Measure	Time frame	Description
Loco-regional tumor control after completion of treatment	6 months	Response Evaluation Criteria in Solid Tumors was used to measure outcome: 1. Complete response (CR): Disappearance of all target lesions. 2. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. 3. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. 4. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Treatment related toxicities during and after treatment	8 months	National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026