Squamous Cell Carcinoma of the Head and NeckPhase 3NCT00442455

Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck

A Phase 3 study testing Erlotinib chlorhydrate, Cisplatin and Radiation therapy in people with Squamous Cell Carcinoma of the Head and Neck, run by Grupo de Investigación Clínica en Oncología Radioterapia at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to determinate the free-progression interval in patients with surgically resected locally advanced squamous cell carcinoma of head and neck treated with the maximum tolerated dose of the combination of erlotinib, radiation therapy and cisplatin, previously established in a safety trial. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Squamous Cell Carcinoma of the Head and Neck
What is being tested?: Erlotinib chlorhydrate, Cisplatin and Radiation therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 5 sitesSpain
Study dates: Jan 2006to Aug 2015
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
Surgical resection must have taken place within 8 weeks prior to the patient's inclusion in the study.
In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0.
Age 18-70 years.
Anticipated life expectancy of ≥ 12 weeks.
Patients should have at least one of the following criteria:

Show all 23Show fewer

Pathological T3-4 tumor stage, apart from T3N0 of the larynx with negative margins
Pathological N2-3 nodal stage.
Unfavorable pathological findings such as extranodal spread, positive resection margins, perineural and/or vascular involvement.
Written informed consent given by the patient.
Therapeutic compliance of the patient and geographical proximity to the hospital to facilitate appropriate follow-up.
ECOG 0-1.
No distant metastatic disease.
Adequate organ function according to the following criteria:
Adequate bone marrow reserve: ANC > 1,5 x 10(9) cells/L; Platelet count > 100 x 10(9) cells/L; Hemoglobin > 9 g/dL
Liver function: Bilirubin < 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN
Renal function: calculated creatinine clearance (CrCl) > 60ml/min or Creatinine (Cr) < 1.5 ULN of the reference laboratory.
Serum calcium and alkaline phosphatase must be normal.
Women of child bearing potential must have a negative pregnancy test within the 48h prior to the start of the treatment.
Patients of both genders at a fertile age must follow effective contraceptive measures.
Absence of symptomatic coronary artery disease or acute myocardial infarction within 6 months prior to study.
Patients capable of oral deglutition or requiring gastrostomy.
No problems of intestinal transit such as malabsorption syndrome, chronic inflammatory bowel disease and other diseases, which might impair drug absorption

Who cannot join

Histology other than squamous cell carcinoma.
Presence of macroscopic residual disease.
Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents.
Incomplete resection of the primary tumor or incomplete neck dissection.
Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.
Pregnant or nursing women.

Show all 14Show fewer

Active infection.
Concomitant severe illness (according to the opinion of the investigator) or whose estimated survival for this concomitant pathology is lower than that estimated for the neoplasm disease.
Uncontrolled psychiatric illness.
Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer.
Impossibility to appropriate follow-up.
Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding suggesting a condition that contraindicates the use of the study medication (erlotinib, cisplatin, radiotherapy), which might interfere with the analysis of the results or increase the risk of treatment complications.
Any known significant ophthalmologic abnormalities, including severe xerophthalmia, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratopathy or other abnormalities, which may increase the risk of corneal epithelial damage (the use of contact lenses during the study may increase the risk of corneal damage and its use is strongly discouraged. Those patients still using contact lenses will need a closer ophthalmologic follow-up.
Frequent vomiting or medical disorder impairing swallowing of drugs

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Spain5 sites

Hospital Clínico San Carlos
Madrid, 28003
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Clínica Puerta de Hierro
Madrid, 28035
Hospital Regional Universitario Carlos Haya
Málaga, 29010
Hospital de Navarra
Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Phase I/II Trial of Erlotinib, Radiation Therapy, and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck

Read the detailed description

Phase I:

3 cohorts of 3-6 patients, patients will received:

Erlotinib 100-150 mg/day po for 7 weeks.
Cisplatin 30-40 mg/m2 iv weekly for 7 weeks.
Radiation therapy 63 Gy, five days a week, for 7 weeks. Cohort 1: 3 patients will be included in cohort 1.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the first cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated, after patient 6 has completed the 7-weeks treatment.
If DLT has been recorded in one out of the patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated, after patient 6 has completed the 7-weeks treatment.
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 1, during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

If DLT has been recorded in 2 patients of the first three patients during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Cohort 2:

If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 1, 3 patients will be included in cohort 2.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the second cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated, after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated, after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 2 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

If DLT has been recorded in 2 patients of the first three patients of cohort 2 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Cohort 3:

If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 2, 3 patients will be included in cohort 2.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, then the Maximum Tolerated Dose has not been reached.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the third cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle, then the Maximum Tolerated Dose has not been reached.
If DLT has been recorded in one out of the patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle, then the Maximum Tolerated Dose has not been reached.
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 3 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

If DLT has been recorded in 2 patients of the first three patients of cohort 3 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed

DLT is defined as:

Any clinically intolerable hematological or non-hematological grade 3-4 toxicity.
Grade 3-4 diarrhoea.
Grade 3-4 or clinically intolerable grade 2 skin rash.
Grade 4 mucositis implying a temporary interruption of radiation therapy (for longer than 2 consecutive weeks).
Grade 4 mucositis occurring within the first 3 weeks of treatment.
Grade 3-4 mucositis accompanied by one of the following toxicities:
Worsening of performance status, defined as ECOG ≥ 2 or a decrease of 40% in the Karnofsky performance status scale.
Grade 3 Weight loss (corresponding to a weight loss of ≥ 20% with respect to baseline weight).
Underlying pain (not including swallowing) VAS > 7.
Parenteral nutrition.
Any clinically significant toxicity, involving treatment interruption for a period longer than two weeks.

Maximum Tolerated Dose is defined as the dose level at which 2 patients of the first three patients of one cohort or ≥ 3 of the 6 patients of one cohort exhibit one DLT, during the 7-weeks treatment.

Phase II:

75 patients will be treated at dose step below MTD to determinate:

Progression Free Survival, defined as the period of time from the surgery until disease progression or death.
Overall survival.
Locoregional progression-free survival.

A tumor assessment will be performed 30 days after the end of treatment and every 3 months until disease progression afterwards.

Conditions: Squamous Cell Carcinoma of the Head and Neck
Being tested: Erlotinib chlorhydrate, Cisplatin, Radiation therapy
Keywords: Head Neck Carcinoma Erlotinib
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

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

Erlotinib chlorhydrateDrug
Also called Erlotinib clorhidrate
150 mg/day for 7 weeks
CisplatinDrug
Also called Cisplatino
30 mg/m2 i.v. weekly for 7 weeks
Radiation therapyProcedure or surgery
63 Gy, five days a week, for 7 weeks

Study groups in NCT00442455
Study group	Role	What they receive
Erlotinib, radiotherapy.	Experimental	There are three cohorts of patients in whom the dose of Erlotinib chlorhydrate(100 and 150 mg) and Cisplatin (30 and 40 mg / m2) will be increase, and the doses of Radiation therapy being fixed (63 Gy during 5 days a week during 7 weeks) Receives: Drug: Erlotinib chlorhydrate; Drug: Cisplatin; Procedure: Radiation therapy

What is being measured

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

Determinate the maximum tolerated dose (PHASE I)
Measured: 17/MAR/08
Progression free survival (PHASE II)
Measured: 5 years

Secondary outcomes (2)

DLT (PHASE I)
Measured: 17/MAR/08
Overall survival and locoregional progression free survival (PHASE II)
Measured: 5 years

Timeline

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

Jan 2006Aug 2015

First posted2 Mar 2007 (estimated)
Study startJan 2006
Primary completionAug 2015
Study completionAug 2015

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 the Head and NeckStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442455
Sponsor's protocol ID: ML 18729
Status last verified: May 2019
First submitted: 1 Mar 2007
Last updated: 6 Jun 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Squamous Cell Carcinoma of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Trial of Erlotinib, Radiation Therapy, and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT00442455
Acronym / sponsor ID: ML 18729
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Head Neck Carcinoma Erlotinib
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
Study start: Jan 2006
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 2 Mar 2007 (estimated)
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.

Detailed description

Phase I:

3 cohorts of 3-6 patients, patients will received:

Erlotinib 100-150 mg/day po for 7 weeks.
Cisplatin 30-40 mg/m2 iv weekly for 7 weeks.
Radiation therapy 63 Gy, five days a week, for 7 weeks. Cohort 1: 3 patients will be included in cohort 1.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the first cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated, after patient 6 has completed the 7-weeks treatment.
If DLT has been recorded in one out of the patients 4 to 6 of cohort 1 during the 7-weeks treatment cycle, the dose level of erlotinib will be escalated to 150 mg and enrollment of cohort 2 will be initiated, after patient 6 has completed the 7-weeks treatment.
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 1, during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Cohort 2:

If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 1, 3 patients will be included in cohort 2.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the second cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated, after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in one out of the patients 4 to 6 of cohort 2 during the 7-weeks treatment cycle, the dose level of cisplatin will be escalated to 40 mg/m2 and enrollment of cohort 3 will be initiated, after patient 6 has completed the 7-weeks treatment
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 2 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Cohort 3:

If DLT has been recorded in one out of the first three patients or 1-2 of the 6 patients in cohort 2, 3 patients will be included in cohort 2.

If no DLT has been recorded in the first three patients during the 7-weeks treatment, then the Maximum Tolerated Dose has not been reached.

If DLT has been recorded in one out of the first three patients during the during the 7-weeks treatment, then the third cohort will be expanded to 6 patients.

If no further DLT has been recorded in patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle, then the Maximum Tolerated Dose has not been reached.
If DLT has been recorded in one out of the patients 4 to 6 of cohort 3 during the 7-weeks treatment cycle, then the Maximum Tolerated Dose has not been reached.
If DLT has been recorded in 2 patients of the patients 4 to 6 of cohort 3 during the during the 7-weeks treatment, then the trial will be terminated and this dose level will be considered as the Maximum Tolerated Dose (MTD).

Inclusion of the third patient of each cohort will not be allowed until the safety data from the two previous patients have been analyzed

DLT is defined as:

Any clinically intolerable hematological or non-hematological grade 3-4 toxicity.
Grade 3-4 diarrhoea.
Grade 3-4 or clinically intolerable grade 2 skin rash.
Grade 4 mucositis implying a temporary interruption of radiation therapy (for longer than 2 consecutive weeks).
Grade 4 mucositis occurring within the first 3 weeks of treatment.
Grade 3-4 mucositis accompanied by one of the following toxicities:
Worsening of performance status, defined as ECOG ≥ 2 or a decrease of 40% in the Karnofsky performance status scale.
Grade 3 Weight loss (corresponding to a weight loss of ≥ 20% with respect to baseline weight).
Underlying pain (not including swallowing) VAS > 7.
Parenteral nutrition.
Any clinically significant toxicity, involving treatment interruption for a period longer than two weeks.

Phase II:

75 patients will be treated at dose step below MTD to determinate:

Progression Free Survival, defined as the period of time from the surgery until disease progression or death.
Overall survival.
Locoregional progression-free survival.

A tumor assessment will be performed 30 days after the end of treatment and every 3 months until disease progression afterwards.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erlotinib, radiotherapy.	Experimental	Drug: Erlotinib chlorhydrate, Drug: Cisplatin, Procedure: Radiation therapyThere are three cohorts of patients in whom the dose of Erlotinib chlorhydrate(100 and 150 mg) and Cisplatin (30 and 40 mg / m2) will be increase, and the doses of Radiation therapy being fixed (63 Gy during 5 days a week during 7 weeks)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
Surgical resection must have taken place within 8 weeks prior to the patient's inclusion in the study.
In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0.
Age 18-70 years.
Anticipated life expectancy of ≥ 12 weeks.

Key exclusion criteria (14 listed)

Histology other than squamous cell carcinoma.
Presence of macroscopic residual disease.
Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents.
Incomplete resection of the primary tumor or incomplete neck dissection.
Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.

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
Erlotinib chlorhydrateAlso: Erlotinib clorhidrate150 mg/day for 7 weeks	Drug	Erlotinib, radiotherapy.
CisplatinAlso: Cisplatino30 mg/m2 i.v. weekly for 7 weeks	Drug	Erlotinib, radiotherapy.
Radiation therapy63 Gy, five days a week, for 7 weeks	Procedure or surgery	Erlotinib, radiotherapy.

Primary outcome

Determinate the maximum tolerated dose (PHASE I)
Time frame: 17/MAR/08
Progression free survival (PHASE II)
Time frame: 5 years

2 secondary outcomes

DLT (PHASE I)
Time frame: 17/MAR/08
Overall survival and locoregional progression free survival (PHASE II)
Time frame: 5 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 6 Jun 2019.

Related trials for Squamous Cell Carcinoma of the Head and Neck

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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.

Felipe Calvo Manuel, Dr. study director

Hospital General Universitario Gregorio Marañon

Alejandro de la Torre Tomás, Dr. principal investigator

Hospital Universitario Clínica Puerta de Hierro

Manuel de las Heras González, Dr. principal investigator

Hospital San Carlos, Madrid

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 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: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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?

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?

Determinate the maximum tolerated dose (PHASE I) (time frame: 17/MAR/08). 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 NCT00442455.

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 6 Jun 2019.