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Chemotherapy

Chemoradiotherapy vs Immunotherapy with Radiation for Oral Cancer

Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix I) and a body weight of > 30 kg
Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

Study Summary

This trial is testing whether adding more radiation therapy after the initial treatment will lower the chance of cancer coming back.

Who is the study for?
This trial is for adults with intermediate-risk HPV-positive oropharyngeal squamous cell carcinoma that hasn't spread. They must be in good physical condition, not have had certain previous cancer treatments, and agree to use effective contraception. People with a history of severe allergies to study drugs, other cancers (except some exceptions), autoimmune diseases, uncontrolled illnesses, or who are pregnant can't join.Check my eligibility
What is being tested?
The study compares the effectiveness of cisplatin plus radiotherapy against durvalumab (an immunotherapy drug) plus radiotherapy followed by either more durvalumab or a combination of tremelimumab (another immunotherapy drug) and durvalumab in preventing cancer recurrence.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs or intestines, fatigue, skin reactions, hormonal imbalances and infusion-related symptoms. Cisplatin may cause nausea and kidney issues while radiation could lead to skin irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and weigh more than 30 kg.
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I am using a highly effective method of birth control.
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My cancer is at a specific stage and I have a history of heavy smoking.
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My breast cancer is in stage T1-3 N2, regardless of my smoking history.
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My cancer is in an early stage and I have a history of heavy smoking.
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My throat cancer is confirmed, advanced but not spread to distant parts.
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My tumor is HPV-related, confirmed by a p16 test.
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My recent blood tests show normal organ function and healthy blood cell counts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 year event-free survival
Secondary outcome measures
Cisplatin
Cost-utility will be used to abstract indirect costs at the end of RT and at 6 and 12 months post RT
Distant metastasis-free survival
+10 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Radiation/Durvalumab + Adjuvant Durvalumab/TremelimumabExperimental Treatment3 Interventions
ARM CLOSED TO ACCRUAL WITH AMENDMENT #1
Group II: Radiation/Durvalumab + Adjuvant DurvalumabExperimental Treatment2 Interventions
All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Concurrent Phase: Durvalumab IV 1500 mg, days -7 and 22 (the second dose is given concurrently with RT). Adjuvant Phase (to start 4 weeks after completion of concurrent phase): Durvalumab IV 1500 mg q4 weekly for 6 doses.
Group III: Radiation/CisplatinActive Control2 Interventions
All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Cisplatin IV 100 mg/m2 days 1, 22, 43 concurrently with RT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,657 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,324 Total Patients Enrolled
Anna SpreaficoStudy ChairUNH/Princess Margaret Cancer Centre, Toronto ON Canada
3 Previous Clinical Trials
188 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03410615 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Radiation/Durvalumab + Adjuvant Durvalumab, Radiation/Durvalumab + Adjuvant Durvalumab/Tremelimumab, Radiation/Cisplatin
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03410615 — Phase 2
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410615 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the primary purposes that Durvalumab is used for?

"Durvalumab is an immunotherapy medication that can be used to treat patients with unresectable stage iii non-small cell lung cancer who have not received prior treatment for their disease."

Answered by AI

Has Durvalumab undergone the necessary testing to be approved by the FDA?

"Since this is a Phase 2 trial, meaning that while there is some data supporting safety, there is none yet backing efficacy, our team at Power have given Durvalumab a score of 2."

Answered by AI

How many test subjects are included in this experiment?

"This study isn't looking for new patients right now; however, 801 other trials for carcinoma, squamous cell and 1007 studies involving Durvalumab are."

Answered by AI

Is this clinical trial still recruiting participants?

"Unfortunately, the information available on clinicaltrials.gov suggests that this particular trial is not presently looking for patients. Although it was last updated on November 17th, 2022, the original posting date was January 31st, 2018. However, there are many other trials (1808 at present) which are enrolling patients."

Answered by AI

What is the research history of Durvalumab?

"City of Hope Comprehensive Cancer Center began studying durvalumab in 1997 and, since then, 1102 clinical trials have completed. Out of the 1007 active clinical trials being conducted currently, many are located in Regina, Saskatchewan."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC
2018. "Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03410615.
~29 spots leftby Jan 2026
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