Squamous Cell Carcinoma of Oral CavityEarly Phase 1NCT03923998
Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers
A Early Phase 1 study testing Neoadjuvant chemotherapy, Neoadjuvant radiotherapy and Resection and reconstruction in people with Squamous Cell Carcinoma of Oral Cavity, run by Indrayani Hospital and Cancer Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Oral Cavity
- What is being tested?
- Neoadjuvant chemotherapy, Neoadjuvant radiotherapy and Resection and reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2016to 15 Mar 2019
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity.
- Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla.
- Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity.
Who cannot join
- Patients with distant metastases.
- Patients with contraindication to radiotherapy.
- Patients with vascular disorders or ischemic heart disease. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
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.
Read the detailed description
This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of patients who have not been treated previously. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. After reviewing the histopathological report, the patients will be treated as per the study protocol. The patients will be under regular follow-up with 3 monthly intervals for a period of one year and 6 monthly period in the following years. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of inclusion and the date of biopsy-proven recurrence. We will also record the overall survival, parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4)
Study protocol:
- Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
- Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
- Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of radiotherapy treatment. Delay is required for planning of implant position in the fibula.
- Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.
- Conditions
- Squamous Cell Carcinoma of Oral Cavity
- Being tested
- Neoadjuvant chemotherapy, Neoadjuvant radiotherapy, Resection and reconstruction
- Keywords
- Oral neoplasms, Mouth neoplasms
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
Also called NACT
Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
Neoadjuvant radiotherapyRadiation
Also called NACTRT
Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
Resection and reconstructionProcedure or surgery
Also called Mandibulectomy/Maxillectomy and reconstruction by free fibula flap
Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy followed by surgery | Experimental | Preoperative chemotherapy with concurrent radiotherapy followed by definitive surgery Receives: Drug: Neoadjuvant chemotherapy; Radiation: Neoadjuvant radiotherapy; Procedure: Resection and reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.
Measured: Upto 1 year
Disease free survival
Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).
Measured: 2 years
Overall Survival
Overall Survival will be calculated as the time interval (months) between primary treatment and death.
Measured: 2 years
Secondary outcomes (1)
Quality of life assessment
Patient reported quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4). The minimum score is 0 which is indicative of worse outcome while 100 is the maximum score and indicative of better outcome. Various parameters including chewing, pain, swallowing, saliva, appearance etc. are included in the questionnaire. Average score for each parameter with standard deviation will be reported.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start15 Mar 2016
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indrayani Hospital and Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Capital Limited, Grant Medical Foundation Ruby hall Clinic
- Responsible party
- Principal investigator, Dr. Sanjay Deshmukh, Indrayani Hospital and Cancer Institute
- Investigators
- Sanjay Deshmukh, MS, Principal investigator, Indrayani Hospital and Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923998
- Sponsor's protocol ID
- OIT415
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data for all primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Neoadjuvant Chemoradiotherapy as a Treatment Plan for Patients With Stage IVa Oral Cancer.
- ClinicalTrials.gov ID
- NCT03923998
- Acronym / sponsor ID
- OIT415
- Conditions
- Squamous Cell Carcinoma of Oral Cavity
- Keywords
- Oral neoplasms, Mouth neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indrayani Hospital and Cancer InstituteUniversity, hospital or other
- Collaborators
- Tata Capital Limited, Grant Medical Foundation Ruby hall Clinic
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of patients who have not been treated previously. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. After reviewing the histopathological report, the patients will be treated as per the study protocol. The patients will be under regular follow-up with 3 monthly intervals for a period of one year and 6 monthly period in the following years. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of inclusion and the date of biopsy-proven recurrence. We will also record the overall survival, parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4)
Study protocol:
- Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
- Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
- Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of radiotherapy treatment. Delay is required for planning of implant position in the fibula.
- Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy followed by surgery | Experimental | Drug: Neoadjuvant chemotherapy, Radiation: Neoadjuvant radiotherapy, Procedure: Resection and reconstructionPreoperative chemotherapy with concurrent radiotherapy followed by definitive surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity.
- Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla.
- Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity.
Key exclusion criteria (3 listed)
- Patients with distant metastases.
- Patients with contraindication to radiotherapy.
- Patients with vascular disorders or ischemic heart disease. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapyAlso: NACTThree weekly concurrent chemotherapy with cisplatin 100 mg /m2 | Drug | Neoadjuvant chemoradiotherapy followed by surgery |
| Neoadjuvant radiotherapyAlso: NACTRTPreoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys | Radiation | Neoadjuvant chemoradiotherapy followed by surgery |
| Resection and reconstructionAlso: Mandibulectomy/Maxillectomy and reconstruction by free fibula flapResection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft | Procedure or surgery | Neoadjuvant chemoradiotherapy followed by surgery |
Primary outcome
Objective response rate
Time frame: Upto 1 year
This will be deduced from pathological response in terms of complete and partial response. Complete response is defined as no invasive and no in situ residuals present in the surgical specimen. Partial response defined as at least a 30% reduction in the size of the lesion in the surgical specimen.
Disease free survival
Time frame: 2 years
Disease-free survival will be calculated as the time interval (months) between primary treatment and the first recurrence (whether local, regional or distant).
Overall Survival
Time frame: 2 years
Overall Survival will be calculated as the time interval (months) between primary treatment and death.
1 secondary outcome
Quality of life assessment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Yes. Individual patient data for all primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Deshmukh, MS principal investigator
Indrayani Hospital and Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neoadjuvant chemotherapy, Neoadjuvant radiotherapy and Resection and reconstruction in people with Squamous Cell Carcinoma of Oral Cavity, run by Indrayani Hospital and Cancer Institute 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Upto 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2019.