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Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

NCT03923998 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-23

No results posted yet for this study

Summary

Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors (late stage) needs to be evaluated to assess its benefit before surgery.

Conditions

  • Squamous Cell Carcinoma of Oral Cavity

Interventions

DRUG

Neoadjuvant chemotherapy

Three weekly concurrent chemotherapy with cisplatin 100 mg /m2

RADIATION

Neoadjuvant radiotherapy

Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys

PROCEDURE

Resection and reconstruction

Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft

Sponsors & Collaborators

  • Tata Capital Limited

    collaborator UNKNOWN

  • Grant Medical Foundation Ruby hall Clinic

    collaborator UNKNOWN

  • Indrayani Hospital and Cancer Institute

    lead OTHER

Principal Investigators

  • Sanjay Deshmukh, MS · Indrayani Hospital and Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923998 on ClinicalTrials.gov