NCT05050162|SuspendedPhase 2

Study Stopped

End of Initial Phase of Multi-phase protocol; closed for protocol specified analysis

Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer

Randomized Phase II/III Trial of Radiation With Cisplatin at 100 mg/m2 Every Three Weeks Versus Radiation With Weekly Cisplatin at 40 mg/m2 for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NRG Oncology ClinicalTrials.gov

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3 other identifiers

NRG-HN009NCI-2021-08925U10CA180868

Study Type

interventional

Target

1,714

Locations

5 countries

Sites

370

Timeline

RegisteredSep 2021

StartedFeb 2022

CompletionFeb 2027

Brief Summary

This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

1,714

participants targeted

Target at P75+ for phase_2

Timeline

8mo left

Started Feb 2022

Longer than P75 for phase_2

Geographic Reach

5 countries

370 active sites

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 years study duration

Study Progress87%

Feb 2022Feb 2027

First Submitted

Initial submission to the registry

September 9, 2021

Completed

11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed

4 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2027

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

September 9, 2021

Last Update Submit

May 5, 2026

Conditions

Advanced Hypopharyngeal Squamous Cell Carcinoma Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Advanced Head and Neck Squamous Cell Carcinoma Advanced Laryngeal Squamous Cell Carcinoma Advanced Oropharyngeal Squamous Cell Carcinoma Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8 Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (3)

Incidence of acute toxicity (Phase II)
Measured by the T-scores.
Up to 180 days post-treatment
Overall survival (OS) (Phase III)
OS rates will be estimated using the Kaplan-Meier method.
From randomization to death of any cause, assessed up to 9 years
Incidence of acute toxicity (Phase III)
Measured by the T-scores.
Up to 180 days post-treatment

Secondary Outcomes (11)

Locoregional failure rates
Up to 9 years
Distant metastasis
Up to 9 years
Progression-free survival (PFS)
From randomization to locoregional failure, distant metastasis, or death due to any cause, whichever occurs first, assessed up to 9 years
Restricted mean survival time (RMST) for OS
At 3 years
RMST for PFS
At 3 years
+6 more secondary outcomes

Study Arms (2)

ARM I (radiation therapy, every 3 week cisplatin)

ACTIVE COMPARATOR

Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive cisplatin IV once Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, or MRI or PET scan throughout the study.

Drug: CisplatinProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Radiation Therapy

Arm II (radiation therapy, weekly cisplatin)

EXPERIMENTAL

Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive weekly cisplatin IV QW for 7 weeks during radiation therapy in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, or MRI or PET scan throughout the study.

Interventions

CisplatinDRUG

Given cisplatin IV every 3 weeks

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

ARM I (radiation therapy, every 3 week cisplatin)

Computed TomographyPROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography