NCT02285530

Brief Summary

The purpose of this study is to confirm the predictive value of GDF15 expression for TPF induction in T3/T4cN0M0 patients with OSCC

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 22, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
5.1 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

4.1 years

First QC Date

October 22, 2014

Last Update Submit

April 4, 2023

Conditions

Mouth NeoplasmsCarcinoma, Squamous Cell

Keywords

head and neck squamous cell carcinoma, GDF15, TPF

Outcome Measures

Primary Outcomes (1)

  • overall survival

    2-year overall survival rate as a measure by the numbers of living patients

    2 year

Secondary Outcomes (3)

  • disease free survival

    2 year

  • local recurrence free survival

    2 year

  • distant metastasis free survival

    2 year

Study Arms (2)

TPF group

EXPERIMENTAL

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

Drug: TPF induction chemotherapyProcedure: surgery groupRadiation: Post-operative radiotherapy

surgery group

OTHER

Radical resection of the primary lesion and full neck,radiotherapy was arranged 4 to 6 weeks after surgery

Procedure: surgery groupRadiation: Post-operative radiotherapy

Interventions

TPF induction chemotherapyDRUG

TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m\^2), cisplatin(75 mg/m\^2), 5-Fu(750 mg/m\^2/day) for 5 days; 16 days later, the 2nd cycle.

Also known as: TPF protocol group
TPF group
surgery groupPROCEDURE

Radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.

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).
  • GDF1 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, School of Medicine, Shanghai Jiao Tong University

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

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
associate professor,PHD,DDS,MD

Study Record Dates

First Submitted

October 22, 2014

First Posted

November 7, 2014

Study Start

December 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

CN(1)