Locally Advanced Malignant NeoplasmPhase 3INDUCTIONNCT03815903
Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Induction chemotherapy and Chemoradiotherapy in people with Locally Advanced Malignant Neoplasm, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Malignant Neoplasm
- What is being tested?
- Induction chemotherapy and Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Dec 2018to Dec 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
- Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable ** or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
- Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
- It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
- Presence of measurable disease according to RECIST 1.1 criteria;
- ECOG performance status of 0-1;
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- ≥ 18 years;
- Adequate marrow reserve indicated by:
- Absolute neutrophil count (ANC) ≥ 1500 / mm³ or Platelets> 100,000 / mm³
- Hemoglobin ≥ 9 g / dL - red blood cell transfusion will be allowed in the screening period if necessary
- Adequate renal and hepatic function:
- Serum bilirubin ≤ 1.5 times the upper limit of normal the TGO and TGP ≤ 3 upper limit of normal. If hepatic metastasis ≤ 5 upper limit of normal
- Serum creatinine ≤ 1.5 mg / dL and creatinine clearance ≥ 60 mL / min calculated by Cockcroft-Gault.
Who cannot join
- Patient submitted to curative resection of the primary site and / or metastatic site. NOTE: Patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible;
- Radiation therapy or previous chemotherapy for head / neck tumor;
- Patients with occult primary tumor;
- T4 from any site, resectable, with invasion of cartilage or jaw;
- History of BMT or stem cell therapy;
- Synchronous tumor or previous history of neoplasia, except for in situ carcinoma of the cervix, basal cell carcinoma or epidermoid carcinoma. Patients with previous history of cancer already treated and without evidence of disease for more than 3 years may participate in the study;
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- Prophylactic use of G-CSF or GM-CSF two weeks prior to the study;
- Clinically significant heart disease: unstable angina or myocardial infarction 6 months prior to study entry Symptomatic ventricular arrhythmia the ICC classified as NYHA ≥ II • Uncontrolled hypercalcemia;
- Uncontrolled infection;
- Any other comorbidity that the investigator's judgment is inappropriate for the study;
- Peripheral neuropathy> grade 2;
- Hearing loss> grade 2;
- Known positive serology for hepatitis B, hepatitis C or HIV
- Use of antiretrovirals;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784-400
Pedro De Marchi, MD, MSc, +55 17 33216600 ext. 6953, pedrodemarchi@yahoo.com.br
Raiany Carvalho, RN, +55 17 33216600 ext. 6712, raiany.carvalho@hcancerbarretos.com.br
About this study
Official title: A Phase 3, Randomized, Open-label Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.
- Conditions
- Locally Advanced Malignant Neoplasm
- Being tested
- Induction chemotherapy, Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemotherapyDrug
3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2
ChemoradiotherapyCombination product
Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2
| Study group | Role | What they receive |
|---|---|---|
| A - induction chemotherapy | Active comparator | Not described Receives: Drug: Induction chemotherapy; Combination Product: Chemoradiotherapy |
| B - chemoradiotherapy | Experimental | Not described Receives: Combination Product: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years overall survival
Measured: From date of randomization until 3 years
Secondary outcomes (8)
Progression free survival
PFS
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Systemic relapse free survival
Measured: From date of randomization until the date of first systemic relapse or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Overall response rate
Measured: At the end of Cycle 3 of IC (each cycle is 21 days) and 8 weeks after the end of radiotherapy, through study completion, an average of 6 months
Adverse Events Rates
Measured: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).
1-year functional organ preservation rate
Measured: From date of randomization until 1 year after
Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: From date of randomization until 5 years
Overall response rate to induction chemotherapy
Measured: At the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start19 Dec 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant NeoplasmStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815903
- Sponsor's protocol ID
- BarretoCH - 201801
- Acronym
- INDUCTION
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03815903
- Acronym / sponsor ID
- INDUCTION / BarretoCH - 201801
- Conditions
- Locally Advanced Malignant Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jan 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.
The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - induction chemotherapy | Active comparator | Drug: Induction chemotherapy, Combination Product: Chemoradiotherapy |
| B - chemoradiotherapy | Experimental | Combination Product: Chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
- Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable ** or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
- Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
- It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
- Presence of measurable disease according to RECIST 1.1 criteria;
Key exclusion criteria (14 listed)
- Patient submitted to curative resection of the primary site and / or metastatic site. NOTE: Patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible;
- Radiation therapy or previous chemotherapy for head / neck tumor;
- Patients with occult primary tumor;
- T4 from any site, resectable, with invasion of cartilage or jaw;
- History of BMT or stem cell therapy;
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 |
|---|---|---|
| Induction chemotherapy3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2 | Drug | A - induction chemotherapy |
| ChemoradiotherapyRadiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2 | Combination product | A - induction chemotherapy, B - chemoradiotherapy |
Primary outcome
3-years overall survival
Time frame: From date of randomization until 3 years
8 secondary outcomes
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Systemic relapse free survival
Time frame: From date of randomization until the date of first systemic relapse or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Overall response rate
Time frame: At the end of Cycle 3 of IC (each cycle is 21 days) and 8 weeks after the end of radiotherapy, through study completion, an average of 6 months
Adverse Events Rates
Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).
1-year functional organ preservation rate
Time frame: From date of randomization until 1 year after
Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)
Time frame: From date of randomization until 5 years
Overall response rate to induction chemotherapy
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Induction chemotherapy and Chemoradiotherapy in people with Locally Advanced Malignant Neoplasm, run by Barretos Cancer Hospital at 1 site in Brazil.
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 13 inclusion and 14 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 18 Jul 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years overall survival (time frame: From date of randomization until 3 years). 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 18 Jul 2019.