NCT02290145

Brief Summary

The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started Dec 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2016Dec 2026

First Submitted

Initial submission to the registry

October 22, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

8 years

First QC Date

October 22, 2014

Last Update Submit

November 21, 2023

Conditions

Mouth NeoplasmsCarcinoma, Squamous Cell

Keywords

docetaxel, cisplatin, 5-FU, cyclinD1

Outcome Measures

Primary Outcomes (1)

  • overall survival rate as a measure by the numbers of living patients

    2 year

Secondary Outcomes (3)

  • disease free survival as a measure by the number of patients without recurrence or death

    2 year

  • local recurrence free survival as a measure by the number of patients without recurrence

    2 year

  • distant metastasis free survival as a measure by the number of patients without metastasis

    2 year

Study Arms (2)

TPF group

EXPERIMENTAL

TPF induction chemotherapy followed with surgery and post-operative radiotherapy docetaxel 75mg/m2 cisplatin 75 mg/m2 5-Fu 750 mg/m2/day

Drug: TPF groupProcedure: surgery groupRadiation: Post-operative radiotherapy

surgery group

OTHER

surgery with post-operative radiotherapy

Procedure: surgery groupRadiation: Post-operative radiotherapy

Interventions

TPF groupDRUG

The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day

Also known as: TPF protocol group
TPF group
surgery groupPROCEDURE

The patients in the control group received the radical surgery and post-operative radiotherapy.

TPF groupsurgery group
Post-operative radiotherapyRADIATION

Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

TPF groupsurgery group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 75 years old.
  • Sex: both males and females.
  • Karnofsky performance status (KPS) \>60.
  • Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
  • Cyclin D1 high expression
  • Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[International Union Against Cancer\] 2002) with resectable lesions.
  • Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3.
  • Hepatic function: ALAT(alanine aminotransferase)/ASAT(aspartate transaminase) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN.
  • Renal function: serum creatinine \<1.5 times ULN.
  • Written informed consent

You may not qualify if:

  • Evidence of distant metastatic disease and other cancers.
  • Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
  • Previous radiotherapy or chemotherapy.
  • Other previous malignancies within 5 years.
  • Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
  • Legal incapacity or limited legal capacity.
  • Creatinine clearance \<30ml/min.
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Mouth NeoplasmsCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Central Study Contacts

Lai-pimg Zhong, PHD

CONTACT

+86 021-23271699zhonglaiping@163.com

Ying Liu, MPhil

CONTACT

+86 15021196610alllyliuying@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,PHD,DDS,MD

Study Record Dates

First Submitted

October 22, 2014

First Posted

November 13, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

CN(1)