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Oral Cavity Squamous Cell CarcinomaPhase 2/3NCT02923258

Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer

A Phase 2/3 study testing Docetaxel, Cisplatin and IMRT in people with Oral Cavity Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

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

This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Oral Cavity Squamous Cell Carcinoma
What is being tested?
Docetaxel, Cisplatin and IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
21 Apr 2018to 30 Apr 2023
Phase
Phase 2/3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
  • Histologic extracapsular nodal extension
  • Histologic involvement of ≥ 2 regional lymph nodes
  • Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG 0-1 6. Adequate organ function including the following:
  • <!-- -->
  • Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
Show all 12Show fewer
  • Platelets count >= 100 * 10^9/l
  • Hemoglobin >= 10 g/dl
  • AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
  • Total bilirubin <= 1.5 times institutional ULN
  • Creatinine clearance >= 50 ml/min
  • Serum creatine <= 1 times ULN 7.Signed written informed consent

Who cannot join

  • 1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai ninth people's hospital

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official title: Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial

This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.

Being tested
Docetaxel, Cisplatin, IMRT
Keywords
oral cavity squamous cell carcinoma, concurrent chemotherapy, High-Risk
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • DocetaxelDrug

    20mg/m2/w

  • CisplatinDrug

    100mg/m2/q3w

  • IMRTRadiation

    a total dose of 60Gy in 30fractions over 6 weeks

Study groups in NCT02923258
Study groupRoleWhat they receive
ExperimentalExperimentalConcurrent Chemoradiotherapy With Docetaxel and IMRT
Receives: Drug: Docetaxel; Radiation: IMRT
ControlActive comparatorConcurrent Chemoradiotherapy With Cisplatinum and IMRT
Receives: Drug: Cisplatin; Radiation: IMRT

What is being measured

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

  1. Disease-free survival (DFS)

    Measured: 2 years

Secondary outcomes (4)

  1. Overall Survival (OS)

    the time in months between the date of random assignment and the date of death from any cause

    Measured: 2 years

  2. Locoregional failure-free survival (LRFS)

    the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first

    Measured: 2 years

  3. distant metastasis free survival (DMFS)

    the time from random assignment to the first distant metastasis or death from any cause

    Measured: 2 years

  4. Adverse Events (AE)

    AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Measured: 3 months

Timeline

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

  1. First posted4 Oct 2016 (estimated)
  2. Study start21 Apr 2018
  3. Primary completion28 Feb 2022
  4. Study completion30 Apr 2023

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923258
Sponsor's protocol ID
2016HNRT004
Status last verified
Jun 2024
First submitted
3 Oct 2016
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jiang W, Chen L, Li R, Li J, Dou S, Ye L, He Y, Tian Z, Yao Y, Zhu G. Postoperative radiotherapy with docetaxel versus cisplatin for high-risk oral squamous cell carcinoma: a randomized phase II trial with exploratory analysis of ITGB1 as a potential predictive biomarker. BMC Med. 2024 Jul 29;22(1):314. doi: 10.1186/s12916-024-03541-6.

    PubMed 39075531

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Docetaxel, Cisplatin and IMRT in people with Oral Cavity Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

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 12 inclusion and 1 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 20 Jun 2024. 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 China. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

Disease-free survival (DFS) (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 NCT02923258, which also lists 1 linked publication.

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 20 Jun 2024.

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