Head and Neck Squamous Cell CarcinomaPhase 2HNCNCT03998696

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.

A Phase 2 study testing Cisplatin 40 mg/m2 and Cisplatin 100 mg/m2 in people with Head and Neck Squamous Cell Carcinoma, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

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

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Head and Neck Squamous Cell Carcinoma
What is being tested?: Cisplatin 40 mg/m2 and Cisplatin 100 mg/m2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteBangladesh
Study dates: 1 Jan 2024to 30 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Bangladesh Medical University
Dhaka, 1000

Other trials in Bangladesh

About this study

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

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.

Conditions: Head and Neck Squamous Cell Carcinoma
Being tested: Cisplatin 40 mg/m2, Cisplatin 100 mg/m2
Keywords: Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy
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.

Cisplatin 40 mg/m2Drug
Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
Cisplatin 100 mg/m2Drug
Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.

Study groups in NCT03998696
Study group	Role	What they receive
Arm A	Active comparator	Weekly Cisplatin Receives: Drug: Cisplatin 40 mg/m2
Arm B	Experimental	Three weekly Cisplatin Receives: Drug: Cisplatin 100 mg/m2

What is being measured

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

Loco-regional Tumor Control After Completion of Treatment
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.
Measured: 6 months
Distribution of the Patients by Oral Mucositis
Radiation Therapy Oncology Group (RTOG) toxicity criteria was used to measure toxicities related to oral mucosa.
Grade I: Irritation / may experience mild pain not requiring analgesic. Grade II: Patchy mucositis that may produce an inflammatory serosanguinous discharge / may experience moderate pain requiring analgesia.
Grade III: Confluent fibrinous mucositis / may include severe pain requiring narcotic.
Grade IV: Ulceration, hemorrhage or necrosis.
Measured: 8 months

Timeline

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

1 Jan 202430 Jun 2025

First posted26 Jun 2019
Study start1 Jan 2024
Primary completion31 Dec 2024
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03998696
Sponsor's protocol ID: BMU/2023/1577
Other IDs: 2023/311, 2023/363
Acronym: HNC
Status last verified: Oct 2026
First submitted: 22 Jun 2019
Last updated: 16 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
PubMed 12506176
Geeta SN, Padmanabhan TK, Samuel J, Pavithran K, Iyer S, Kuriakose MA. Comparison of acute toxicities of two chemotherapy schedules for head and neck cancers. J Cancer Res Ther. 2006 Jul-Sep;2(3):100-4. doi: 10.4103/0973-1482.27584.
PubMed 17998687
Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.
PubMed 27602493
Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: a retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncol. 2008;47(8):1513-8. doi: 10.1080/02841860701846160.
PubMed 18607863
Jacinto JK, Co J, Mejia MB, Regala EE. The evidence on effectiveness of weekly vs triweekly cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell carcinoma (HNSCC): a systematic review and meta-analysis. Br J Radiol. 2017 Nov;90(1079):20170442. doi: 10.1259/bjr.20170442.
PubMed 29053029
Lee JY, Sun JM, Oh DR, Lim SH, Goo J, Lee SH, Kim SB, Park KU, Kim HK, Hong DS, Kim JS, Kim SG, Yi SY, Yun HJ, Hyun MS, Kim HJ, Jung SH, Park K, Ahn YC, Ahn MJ. Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02). Radiother Oncol. 2016 Feb;118(2):244-50. doi: 10.1016/j.radonc.2015.11.030. Epub 2015 Dec 17.
PubMed 26705681
Tsan DL, Lin CY, Kang CJ, Huang SF, Fan KH, Liao CT, Chen IH, Lee LY, Wang HM, Chang JT. The comparison between weekly and three-weekly cisplatin delivered concurrently with radiotherapy for patients with postoperative high-risk squamous cell carcinoma of the oral cavity. Radiat Oncol. 2012 Dec 18;7:215. doi: 10.1186/1748-717X-7-215.
PubMed 23245290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma

All Head and Neck Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer
ClinicalTrials.gov ID: NCT03998696
Acronym / sponsor ID: HNC / BMU/2023/1577
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Locally advanced, Head and Neck Cancer, Concurrent, Weekly Cisplatin, Three weekly Cisplatin, Radiotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 26 Jun 2019 (actual)
Results: Posted 16 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Active comparator	Drug: Cisplatin 40 mg/m2Weekly Cisplatin
Arm B	Experimental	Drug: Cisplatin 100 mg/m2Three weekly Cisplatin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cisplatin 40 mg/m2Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.	Drug	Arm A
Cisplatin 100 mg/m2Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.	Drug	Arm B

Primary outcome

Loco-regional Tumor Control After Completion of Treatment
Time frame: 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.
Distribution of the Patients by Oral Mucositis
Time frame: 8 months
Radiation Therapy Oncology Group (RTOG) toxicity criteria was used to measure toxicities related to oral mucosa. Grade I: Irritation / may experience mild pain not requiring analgesic. Grade II: Patchy mucositis that may produce an inflammatory serosanguinous discharge / may experience moderate pain requiring analgesia. Grade III: Confluent fibrinous mucositis / may include severe pain requiring narcotic. Grade IV: Ulceration, hemorrhage or necrosis.

Results and safety

Results posted to the registry on 16 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A	30	30
Arm B	30	30

Primary outcome: Loco-regional Tumor Control After Completion of Treatment

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Arm A n = 30	Arm B n = 30
Complete response	19	23
Partial response	8	5
Progressive disease	3	2

Arm A vs Arm B: p = 0.534, Fisher Exact

Primary outcome: Distribution of the Patients by Oral Mucositis

Time frame: 8 months. Count of participants. Unit: Participants

Measure	Arm A n = 30	Arm B n = 30
Grade I oral mucositis	4	16
Grade II oral mucositis	18	10
Grade III oral mucositis	8	4

Arm A vs Arm B: p = 0.004, Fisher Exact

Adverse events

Time frame: 8 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 30 (0%)	30 of 30 (100%)	0 of 30
Arm B	0 of 30 (0%)	30 of 30 (100%)	0 of 30

Limitations and caveats (from the sponsor): 1. Non-randomized study - unable to prevent selection bias. 2. Short study period - late toxicities and survival data could not be measured. 3. Sample size - great limitation to get an accurate clinical outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12506176Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
Background: PubMed 17998687Geeta SN, Padmanabhan TK, Samuel J, Pavithran K, Iyer S, Kuriakose MA. Comparison of acute toxicities of two chemotherapy schedules for head and neck cancers. J Cancer Res Ther. 2006 Jul-Sep;2(3):100-4. doi: 10.4103/0973-1482.27584.
Background: PubMed 27602493Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.
Background: PubMed 18607863Ho KF, Swindell R, Brammer CV. Dose intensity comparison between weekly and 3-weekly Cisplatin delivered concurrently with radical radiotherapy for head and neck cancer: a retrospective comparison from New Cross Hospital, Wolverhampton, UK. Acta Oncol. 2008;47(8):1513-8. doi: 10.1080/02841860701846160.
Background: PubMed 29053029Jacinto JK, Co J, Mejia MB, Regala EE. The evidence on effectiveness of weekly vs triweekly cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell carcinoma (HNSCC): a systematic review and meta-analysis. Br J Radiol. 2017 Nov;90(1079):20170442. doi: 10.1259/bjr.20170442.
Background: PubMed 26705681Lee JY, Sun JM, Oh DR, Lim SH, Goo J, Lee SH, Kim SB, Park KU, Kim HK, Hong DS, Kim JS, Kim SG, Yi SY, Yun HJ, Hyun MS, Kim HJ, Jung SH, Park K, Ahn YC, Ahn MJ. Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02). Radiother Oncol. 2016 Feb;118(2):244-50. doi: 10.1016/j.radonc.2015.11.030. Epub 2015 Dec 17.
Background: PubMed 23245290Tsan DL, Lin CY, Kang CJ, Huang SF, Fan KH, Liao CT, Chen IH, Lee LY, Wang HM, Chang JT. The comparison between weekly and three-weekly cisplatin delivered concurrently with radiotherapy for patients with postoperative high-risk squamous cell carcinoma of the oral cavity. Radiat Oncol. 2012 Dec 18;7:215. doi: 10.1186/1748-717X-7-215.
Global Cancer Observatory (GLOBOCAN), 2018.Link provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Head and Neck Squamous Cell Carcinoma

RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
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RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarwar Alam, MBBS, Mphil study chair

Bangladesh Medical University, Dhaka, Bangladesh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 7 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 16 Oct 2026. 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 Bangladesh. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Loco-regional Tumor Control After Completion of Treatment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03998696, which also lists 7 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 16 Oct 2026.