CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 48 target
Drug / intervention
TPF group +2 moredrug
Likely dose
TPF group 75mg/m2from record
Key inclusion· 7
  • ✓Age 18 to 75 years old
  • ✓Both males and females
  • ✓Karnofsky performance status >60
  • ✓Histological confirmation of squamous cell carcinoma of oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, retromolar region)
Key exclusion· 9
  • ✕Distant metastatic disease
  • ✕Other malignancies
  • ✕Prior surgical procedure of primary tumors or lymph nodes (except diagnostic biopsy)
  • ✕Previous radiotherapy or chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02290145
NCT02290145Phase 2RecruitingUpdate OverdueUpdated 31mo ago · Completion was 18mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial

Shanghai Jiao Tong University School of Medicine·interventional·Posted Nov 13, 2014·Updated Nov 22, 2023

In Brief

A Phase 2 clinical trial evaluating TPF group, surgery group, and 1 other intervention for Mouth Neoplasms and Carcinoma, Squamous Cell. Currently recruiting, targeting 48 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMouth Neoplasms, Carcinoma, Squamous Cell
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2015201620172018201920202021202220232024202520262027
First PostedNov 13, 2014
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2024
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 11.6 years ago

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

surgery groupprocedure

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

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.