Radiotherapy; ComplicationsHIPOCPNCT03194061
Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer
A study testing Hypofractionated Radiotherapy and Weekly cisplatin in people with Radiotherapy; Complications, run by Barretos Cancer Hospital.
Trial summary
The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy; Complications
- What is being tested?
- Hypofractionated Radiotherapy and Weekly cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Aug 2019
- Phase
- Interventional
- 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
- Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
- Stage III an IV, with no distant metastasis.
- ECOG performance status 0-2.
- Adequate renal and liver function.
- Good status for radical treatment
Who cannot join
- Other oncologic treatment before
- Distant metastasis
- History of previous malignancy
About this study
Official title: Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.
Read the detailed description
To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.
Patients eligibility criteria:
older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment
Treatment considered feasible if:
- Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)
- Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)
- Treatment length up to 35 days.
- Grade 4 toxicity lower than 25%
- Conditions
- Radiotherapy; Complications
- Being tested
- Hypofractionated Radiotherapy, Weekly cisplatin
- Keywords
- chemotherapy, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiotherapyRadiation
20 fractions of 275cGy 5 days/week
Weekly cisplatinDrug
Concomitant weekly cisplatin 35mg/m2 x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated chemoradiation | Experimental | 20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles Receives: Radiation: Hypofractionated Radiotherapy; Drug: Weekly cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of patient who could complete the treatment.
The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.
Measured: up to 5 years after patient accrual
To evaluate the rate of participants with treatment-related adverse events
as assessed by investigators using the CTCAE v4.0 criteria
Measured: up to 5 years after patient accrual
Secondary outcomes (2)
Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.
Measured: up to 18 months from treatment
Response rate
as determined by investigators using RECIST v1.1 criteria
Measured: up to 4 months after patient accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jan 2015
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy; ComplicationsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre A Jacinto, MD, Principal investigator, Barretos Cancer HospitalAndre Lopes Carvalho, Phd, Study director, Barretos Cancer HospitalLuciano Souza Viana, Phd, Study chair, Barretos Cancer HospitalPedro de Marchi, Study chair, Barretos Cancer HospitalEronides Salustiano Batalha, Study chair, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194061
- Sponsor's protocol ID
- HIPO CP.
- Acronym
- HIPOCP
- Status last verified
- Jun 2017
- First submitted
- 24 Apr 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacinto AA, Batalha Filho ES, Viana LS, De Marchi P, Capuzzo RC, Gama RR, Boldrini Junior D, Santos CR, Pinto GDJ, Dias JM, Canton HP, Carvalho R, Radicchi LA, Bentzen S, Zubizarreta E, Carvalho AL. Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma. BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5.
PubMed 30352576
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03194061
- Acronym / sponsor ID
- HIPOCP / HIPO CP.
- Conditions
- Radiotherapy; Complications
- Keywords
- chemotherapy, complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 21 Jun 2017 (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 aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.
Detailed description
To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.
Patients eligibility criteria:
older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment
Treatment considered feasible if:
- Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)
- Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)
- Treatment length up to 35 days.
- Grade 4 toxicity lower than 25%
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated chemoradiation | Experimental | Radiation: Hypofractionated Radiotherapy, Drug: Weekly cisplatin20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
- Stage III an IV, with no distant metastasis.
- ECOG performance status 0-2.
- Adequate renal and liver function.
- Good status for radical treatment
Key exclusion criteria (3 listed)
- Other oncologic treatment before
- Distant metastasis
- History of previous malignancy
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 |
|---|---|---|
| Hypofractionated Radiotherapy20 fractions of 275cGy 5 days/week | Radiation | Hypofractionated chemoradiation |
| Weekly cisplatinConcomitant weekly cisplatin 35mg/m2 x 4 weeks | Drug | Hypofractionated chemoradiation |
Primary outcome
To evaluate the rate of patient who could complete the treatment.
Time frame: up to 5 years after patient accrual
The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.
To evaluate the rate of participants with treatment-related adverse events
Time frame: up to 5 years after patient accrual
as assessed by investigators using the CTCAE v4.0 criteria
2 secondary outcomes
Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
Time frame: up to 18 months from treatment
Response rate
Time frame: up to 4 months after patient accrual
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Derived from this study: PubMed 30352576Jacinto AA, Batalha Filho ES, Viana LS, De Marchi P, Capuzzo RC, Gama RR, Boldrini Junior D, Santos CR, Pinto GDJ, Dias JM, Canton HP, Carvalho R, Radicchi LA, Bentzen S, Zubizarreta E, Carvalho AL. Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma. BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5.
- Individual participant dataSharing planned: No
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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.
Alexandre A Jacinto, MD principal investigator
Barretos Cancer Hospital
Andre Lopes Carvalho, Phd study director
Barretos Cancer Hospital
Luciano Souza Viana, Phd study chair
Barretos Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiotherapy and Weekly cisplatin in people with Radiotherapy; Complications, run by Barretos Cancer Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
To evaluate the rate of patient who could complete the treatment. (time frame: up to 5 years after patient accrual). The study lists 2 primary outcomes in all. 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 NCT03194061, which also lists 1 linked publication.
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 19 Jan 2018.