NCT03923998

Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Completed EARLY_PHASE1 Last updated 23 April 2019

What this trial tests

EARLY_PHASE1 trial testing Neoadjuvant chemotherapy in Squamous Cell Carcinoma of Oral Cavity in 8 participants. Completed in 15 March 2019.

Timeline

15 March 2016

Primary endpoint
15 March 2019

15 March 2019

Quick facts

Lead sponsor	Indrayani Hospital and Cancer Institute
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 March 2016
Primary completion	15 March 2019
Estimated completion	15 March 2019
Sites	1 location across India

Drugs / interventions tested

• Neoadjuvant chemotherapy — full drug profile →
• Neoadjuvant radiotherapy
• Resection and reconstruction

Conditions studied

• Squamous Cell Carcinoma of Oral Cavity — all drugs for Squamous Cell Carcinoma of Oral Cavity →

Sponsor

Indrayani Hospital and Cancer Institute

Who can join

Adults 18 to 70, any sex, with Squamous Cell Carcinoma of Oral Cavity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.