Dose Escalation Versus Standard in Laryngopharyngeal Cancers (NCT02757222) | Clinical Trial Compass
CompletedNot Applicable
Dose Escalation Versus Standard in Laryngopharyngeal Cancers
India100 participantsStarted 2016-01
Plain-language summary
The primary objective of the study is to establish the safety of using a moderate escalation of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative radiotherapy.
The study will also explore the efficacy (improvement in complete response rates at 2 years) of dose escalation in intermediate and high risk OPC and LH cancers patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
LH Inclusion Criteria ALL of the following inclusion criteria must be met
* Histologically confirmed squamous cell cancer of the larynx or hypopharynx
* Radiotherapy with concomitant chemotherapy as primary therapy
* Induction chemotherapy is permitted
* TNM Stage T3-4, N0-3, M0 or T1/2 with N2-3 disease (Stage III or IV a/b) disease
* WHO performance status of 0 or 1
* Creatinine clearance of more than 50ml/min
* All patients must be suitable to attend regular follow up
OPC inclusion criteria ALL of the following inclusion criteria must be met
* Histologically confirmed squamous cell cancer of the oropharynx
* Radiotherapy with concomitant chemotherapy as primary therapy
* Induction chemotherapy is permitted
* WHO performance status of 0 or 1
* Creatinine clearance of more than 50ml/min
* All patients must be suitable to attend regular follow up
* And any of the stage of disease as seen below HPV (p16) negative: TNM Stage T2-T4, any N stage, M0 disease HPV (p16) Positive: more than 10 pack year history and N2b or N3 disease
LH Exclusion Criteria The patient is ineligible if ANYONE of the following exclusion criteria is met
* Previous radiotherapy to the head and neck region
* Previous malignancy except non-melanoma skin cancer and early stage cancer in remission for at least 5 years following treatment
* Previous or concurrent illness, which in the investigator's opinion would interfere with either completion of therapy or follow-up
* Pre-existing previous speech or swa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with Grade 3 through grade 5 adverse events that are related to dose escalation, graded according to NCI CTCAE version 4.0