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

NCT ID: NCT02985255

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Patients enrolled for the study, who are eligible for Neoadjuvant chemotherapy, 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 Neoadjuvant chemotherapy (weekly thrice) with injection Docetaxel, Cisplatin, and 5-FU. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third cycle. Those who are achieving a Complete Response (CR) would undergo adjuvant chemo-radiotherapy. Subjects who have a partial response (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. If the biopsy in these patients is negative for malignancy, they will undergo adjuvant chemoradiotherapy. Those subjects with stable disease (SD) or progressive disease (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

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Tongue Neoplasms Squamous Cell Carcinoma Anterior Tongue Squamous Cell Carcinoma

Keywords

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Neoadjuvant Chemotherapy Tongue Malignancy Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant Arm

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.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Neoadjuvant Arm

Cisplatin

Intervention Type DRUG

Neoadjuvant Arm

5FU

Intervention Type DRUG

Neoadjuvant Arm

Radiotherapy

Intervention Type RADIATION

Neoadjuvant Arm

Glossectomy

Intervention Type PROCEDURE

Neoadjuvant Arm

Interventions

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Docetaxel

Neoadjuvant Arm

Intervention Type DRUG

Cisplatin

Neoadjuvant Arm

Intervention Type DRUG

5FU

Neoadjuvant Arm

Intervention Type DRUG

Radiotherapy

Neoadjuvant Arm

Intervention Type RADIATION

Glossectomy

Neoadjuvant Arm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthCare Global Enterprise Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Vishal U S Rao

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vishal US Rao, MS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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HealthCare Global Enterprises Ltd

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Vishal US Rao, MS

Role: CONTACT

Phone: 00919739774949

Email: [email protected]

Sataksi Chatterjee, MS

Role: CONTACT

Phone: 00918971966903

Email: [email protected]

Facility Contacts

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Vishal US Rao, MS

Role: primary

Sataksi Chatterjee, MS

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19107949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22009800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19446902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23835714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23182993 (View on PubMed)

Other Identifiers

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HCG/SX/001/2016

Identifier Type: -

Identifier Source: org_study_id