AzTrials
AzTrials

Tongue NeoplasmsPhase 2NCT02985255

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

A Phase 2 study testing Docetaxel, Cisplatin and 5FU in people with Tongue Neoplasms and Squamous Cell Carcinoma, run by HealthCare Global Enterprise Ltd. at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 99 years
What is being tested?
Docetaxel, Cisplatin and 5FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndia
Study dates
Apr 2016to Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Vishal US Rao, MS contact

00919739774949

drvishalrao@yahoo.com

Sataksi Chatterjee, MS contact

00918971966903

sataksis2007@gmail.com

India1 site, 1 recruiting

  • HealthCare Global Enterprises Ltd

    Bangalore, Karnataka, 560027

    Vishal US Rao, MS, 00919739774949, drvishalrao@yahoo.com

    Sataksi Chatterjee, MS, 00918971966903, sataksis2007@gmail.com

    Recruiting

Other trials in India

About this study

Official title: Role of Neo-adjuvant Chemotherapy in Organ Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue

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.

Read the detailed description

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.

Being tested
Docetaxel, Cisplatin, 5FU, Radiotherapy, Glossectomy
Keywords
Neoadjuvant Chemotherapy, Tongue Malignancy, Squamous Cell Carcinoma
Medical subject headings
Tongue Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Neoadjuvant Arm

  • CisplatinDrug

    Neoadjuvant Arm

  • 5FUDrug

    Neoadjuvant Arm

  • RadiotherapyRadiation

    Neoadjuvant Arm

  • GlossectomyProcedure or surgery

    Neoadjuvant Arm

Study groups in NCT02985255
Study groupRoleWhat they receive
Neoadjuvant ArmExperimentalStudy 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.
Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: 5FU; Radiation: Radiotherapy; Procedure: Glossectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Overall Survival

    Overall Survival Rate (Date of diagnosis to date of death or last follow-up) in different sub-cohorts of the study

    Measured: 2 years post treatment completion

  2. Progression Free Survival

    Progression Free Survival Rate (Primary treatment end date to date of progression or last follow-up) in difference sub-cohorts of the study

    Measured: 2 years post treatment completion

  3. Sensitivity and Specificity of PET-CT

    Ability of PETCT (along with HPE and EUA) to detect response rates in study subjects undergoing NACT for Ca Tongue

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985255
Sponsor's protocol ID
HCG/SX/001/2016
Status last verified
Dec 2016
First submitted
29 Sep 2016
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19107949

  • 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.

    PubMed 22009800

  • 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.

    PubMed 19446902

  • 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.

    PubMed 23835714

  • 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.

    PubMed 23182993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Cisplatin and 5FU in people with Tongue Neoplasms and Squamous Cell Carcinoma, run by HealthCare Global Enterprise Ltd. at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vishal US Rao, MS (00919739774949, drvishalrao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue Preservation Rate (time frame: At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985255, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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