Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue

NCT02985255 | Unknown Phase 2

• 1 other identifier: HCG/SX/001/2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice) with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further radiation and/ or chemotherapy will be decided based on the final histopathology (of the surgical specimen) reports. PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment completion.

Conditions

Tongue Neoplasms; Squamous Cell Carcinoma; Anterior Tongue Squamous Cell Carcinoma

Keywords

Neoadjuvant Chemotherapy; Tongue Malignancy; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Tongue Preservation Rate

  A ratio of the number of study subjects who have achieved a complete response and do not require surgery, after 3 cycles of NaCT to the total number of subjects recruited to the study.

  At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment)

Secondary Outcomes (3)

• Overall Survival

  2 years post treatment completion

• Progression Free Survival

  2 years post treatment completion

• Sensitivity and Specificity of PET-CT

  At Baseline and after 12-15 weeks (post 3 cycles of NaCT (Typically 3 weeks))

Study Arms (1)

Neoadjuvant Arm

EXPERIMENTAL

Study Subjects, eligible for NACT would undergo a pretreatment workup with Evaluation Under Anesthesia for tumor Mapping and tissue biopsy along with a PET-CT scan. They would undergo 3 cycles of NACT (weekly thrice) with injection Docetaxel, Cisplatin and 5-FU after which reassessment with PET-CT and EUA +/- biopsy would be done. Those achieving CR would undergo adjuvant CTRT while subjects with PR in PET-CT scan will be reclassified based on the biopsy report. If biopsy is negative for malignancy, they will undergo adjuvant CTRT but would undergo surgery if in the PR group. Subjects with SD or PD would undergo surgery. PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment completion.

Drug: Docetaxel; Drug: Cisplatin; Drug: 5FU; Radiation: Radiotherapy; Procedure: Glossectomy

Interventions

Docetaxel DRUG

Neoadjuvant Arm

Neoadjuvant Arm

Cisplatin DRUG

Neoadjuvant Arm

Neoadjuvant Arm

5FU DRUG

Neoadjuvant Arm

Neoadjuvant Arm

Radiotherapy RADIATION

Neoadjuvant Arm

Neoadjuvant Arm

Glossectomy PROCEDURE

Neoadjuvant Arm

Neoadjuvant Arm

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of newly diagnosed squamous cell carcinoma (well/ moderately/ poorly differentiated) of oral tongue (anterior two third) presenting to Health Care Global Enterprises Ltd between January 2016 to March 2017 will be included in the study.
• Stage III and stage IV (T3, 4 N0-3, M 0) and selected cases of T2 with advanced nodal status will also be included in the study.

You may not qualify if:

• Patients having recurrence/ residual disease of oral tongue.
• Patients who have received alternative treatments before being evaluated for NACT
• Patient who are not fit for NACT
• Patient not able to give consent

Sponsors & Collaborators

• HealthCare Global Enterprise Ltd.: lead

Study Sites (1)

HealthCare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

RECRUITING

Related Publications (5)

• Barringer DA, Hutcheson KA, Sturgis EM, Kies MS, Lewin JS. Effect of induction chemotherapy on speech and swallowing function in patients with oral tongue cancer. Head Neck. 2009 May;31(5):611-7. doi: 10.1002/hed.20989.

  PMID: 19107949 BACKGROUND

• Kies MS, Boatright DH, Li G, Blumenschein G, El-Naggar AK, Brandon Gunn G, Lewin JS, Steinhaus GD, Sturgis EM. Phase II trial of induction chemotherapy followed by surgery for squamous cell carcinoma of the oral tongue in young adults. Head Neck. 2012 Sep;34(9):1255-62. doi: 10.1002/hed.21906. Epub 2011 Oct 19.

  PMID: 22009800 BACKGROUND

• Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.

  PMID: 19446902 BACKGROUND

• Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.

  PMID: 23835714 BACKGROUND

• Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.

  PMID: 23182993 BACKGROUND

MeSH Terms

Conditions

Tongue Neoplasms; Carcinoma, Squamous Cell

Interventions

Docetaxel; Cisplatin; Fluorouracil; Radiotherapy; Glossectomy

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Vishal US Rao, MS

  Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishal US Rao, MS

CONTACT

00919739774949; drvishalrao@yahoo.com

Sataksi Chatterjee, MS

CONTACT

00918971966903; sataksis2007@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: December 7, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)