NCT02285543

Brief Summary

To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared to the standard treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

6.7 years

First QC Date

October 22, 2014

Last Update Submit

November 21, 2023

Conditions

Mouth NeoplasmsCarcinoma, Squamous Cell

Keywords

TPF induction chemotherapy, randomized, trial,OSCC

Outcome Measures

Primary Outcomes (1)

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

    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

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

Drug: TPF induction chemotherapyProcedure: surgeryRadiation: radiotherapy

Control group

OTHER

The patients in the control group received the radical surgery and radiotherapy/chemoradiotherapy.

Procedure: surgeryRadiation: 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. 2 weeks later, surgery. Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy

Also known as: TPF protocol group
TPF group
surgeryPROCEDURE

In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.

Control groupTPF group
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(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

Control groupTPF 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).
  • 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

Location

MeSH Terms

Conditions

Mouth NeoplasmsCarcinoma, Squamous Cell

Interventions

Surgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

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 7, 2014

Study Start

December 1, 2016

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

CN(1)