Squamous Cell Carcinoma of Oral CavityPhase 2NCT03121313
Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+
A Phase 2 study testing tegafur-uracil in people with Squamous Cell Carcinoma of Oral Cavity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Primary Objective: To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes. Secondary Objectives: To determine the 2-year locoregional failure rate. To evaluate the 2-year overall survival (OS) rate. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Oral Cavity
- What is being tested?
- tegafur-uracil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2015to 11 May 2020
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have histologically confirmed squamous cell carcinoma with primary site in the oral cavity.
- Patient must have no distant metastasis in the pre-adjuvant radiotherapy evaluation.
- Patient must have received surgical treatment with pathologically documented extracapsular spreading of lymph node.
- Patient must have no CTCAE 4.0 grading≧2 acute adverse events from previous definite treatment at enrollment.
- Patient must can be enrolled within 1 to 3 months after definite treatment.
- Age between 20 and 70 years old;
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- Patient must have ECOG performance status score 0 or 1;
- Patient must have adequate hematopoietic function which is defined as below:
- white blood cell (WBC) ≥ 4,000/mm3;
- platelet count ≥ 100,000/mm3;
- absolute neutrophil count (ANC) ≥ 1,500/mm3;
- Patients must have adequate hepatic function which is defined as below:
- serum bilirubin level < 1.5 mg/dl;
- sGOT and sGPT < 2.5 x ULN;
- serum creatinine level < 1.5 x ULN;
- All women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study medication;
- Patient with childbearing potential must agree to use a reliable contraceptive method during their participation in the study;
- Patient must have the ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patient who has distant metastasis;
- Patient who has serious concomitant illness which might be aggravated by chemotherapy;
- Other malignancy within 5 years prior to study entry with exception of curative treated basal or squamous cell skin cancer or cervical carcinoma in situ.
- Female patient who is pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang-Gung Memorial Hospital-LinKou
Taoyuan City, 333
About this study
Official title: A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
Primary Objective:
To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.
Secondary Objectives:
- To determine the 2-year locoregional failure rate.
- To evaluate the 2-year overall survival (OS) rate.
- To evaluate the 2-year progression-free survival (PFS) rate.
- To assess the safety profiles.
Read the detailed description
The primary endpoint will be 2-years distant failure rate which will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.
The secondary endpoints are described as follows:
- 2-year locoregional failure rate, 2-year PFS rate and 2-year OS rate will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.
- Safety profile: adverse events will be summarized by CTCAE. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.
Determination of sample size:
The estimated 2-year distant failure rate for squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes is 26%. The 2-year distant failure rate of maintenance treatment with tegafur-uracil in this study is expected to be 13%. Using One Proportional Test with one-sided alpha 0.05 and power 80%, the sample size of 56 subjects will test an effect size of 13% (i.e. 26% vs.13%). With expected dropout rate of 20%, the sample size would be 68 subjects.
- Conditions
- Squamous Cell Carcinoma of Oral Cavity
- Being tested
- tegafur-uracil
- Keywords
- Tegafur-uracil, distant metastasis, oral cavity cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tegafur-uracilDrug
Also called UFUR
| Study group | Role | What they receive |
|---|---|---|
| Maintenance | Experimental | Eligible patient will be given maintenance tegafur-uracil for one year.
Dose of tegafur-uracil will be based on patient's body surface area (BSA):
* BSA < 1.5 m2: tegafur-uracil 300 mg/day (1 capsule three times a day)
* BSA ≥ 1.5 m2: tegafur-uracil 400 mg/day (2 capsules twice a day) Tegafur-uracil will be started after patient has complete the adjuvant radiotherapy and been enrolled into the study. Receives: Drug: tegafur-uracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 2-year distant failure rate
the 2-year distant failure rate calculated from the date of surgery will be measured
Measured: 2 years
Secondary outcomes (4)
the 2-year locoregional failure rate.
the 2-year locoregional failure rate calculated from the date of surgery will be measured.
Measured: 2 years
the 2-year overall survival (OS) rate
the 2-year overall survival rate calculated from the date of surgery will be measured
Measured: 2 years
the 2-year progression-free survival (PFS) rate
the 2-year progression-free survival rate calculated from the date of surgery will be measured.
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events will be measured by NCI-CTCAE version 4.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start26 Feb 2015
- Primary completion11 May 2020 (estimated)
- Study completion11 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Oral CavityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Ming Wang, M.D., Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121313
- Sponsor's protocol ID
- 103-0621A3
- Status last verified
- Sep 2018
- First submitted
- 17 Apr 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao CT, Chang JT, Wang HM, Ng SH, Hsueh C, Lee LY, Lin CH, Chen IH, Huang SF, Cheng AJ, Yen TC. Analysis of risk factors of predictive local tumor control in oral cavity cancer. Ann Surg Oncol. 2008 Mar;15(3):915-22. doi: 10.1245/s10434-007-9761-5. Epub 2007 Dec 29.
PubMed 18165878Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
PubMed 15128893Lam P, Yuen AP, Ho CM, Ho WK, Wei WI. Prospective randomized study of post-operative chemotherapy with levamisole and UFT for head and neck carcinoma. Eur J Surg Oncol. 2001 Dec;27(8):750-3. doi: 10.1053/ejso.2001.1171.
PubMed 11735172Tsukuda M, Ogasawara H, Kaneko S, Komiyama S, Horiuchi M, Inuyama Y, Uemura T, Uchida M, Kamata S, Okuda M, et al. [A prospective randomized trial of adjuvant chemotherapy with UFT for head and neck carcinoma. Head and Neck UFT Study Group]. Gan To Kagaku Ryoho. 1994 Jul;21(8):1169-77. Japanese.
PubMed 8031158Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
PubMed 15128894Liao CT, Lee LY, Huang SF, Chen IH, Kang CJ, Lin CY, Fan KH, Wang HM, Ng SH, Yen TC. Outcome analysis of patients with oral cavity cancer and extracapsular spread in neck lymph nodes. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):930-7. doi: 10.1016/j.ijrobp.2010.07.1988. Epub 2010 Oct 8.
PubMed 20934267
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Maintenance Tegafur-uracil in Patients With Squamous Cell Carcinoma of Oral Cavity With Extracapsular Spreading of Lymph Nodes
- ClinicalTrials.gov ID
- NCT03121313
- Acronym / sponsor ID
- 103-0621A3
- Conditions
- Squamous Cell Carcinoma of Oral Cavity
- Keywords
- Tegafur-uracil, distant metastasis, oral cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 11 May 2020 (estimated)
- Study completion
- 11 May 2020 (estimated)
- First posted
- 20 Apr 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.
Primary Objective:
To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.
Secondary Objectives:
- To determine the 2-year locoregional failure rate.
- To evaluate the 2-year overall survival (OS) rate.
- To evaluate the 2-year progression-free survival (PFS) rate.
- To assess the safety profiles.
Detailed description
The primary endpoint will be 2-years distant failure rate which will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.
The secondary endpoints are described as follows:
- 2-year locoregional failure rate, 2-year PFS rate and 2-year OS rate will be estimated by Kaplan-Meier method with two-sided 95% confidence interval.
- Safety profile: adverse events will be summarized by CTCAE. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.
Determination of sample size:
The estimated 2-year distant failure rate for squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes is 26%. The 2-year distant failure rate of maintenance treatment with tegafur-uracil in this study is expected to be 13%. Using One Proportional Test with one-sided alpha 0.05 and power 80%, the sample size of 56 subjects will test an effect size of 13% (i.e. 26% vs.13%). With expected dropout rate of 20%, the sample size would be 68 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with resected squamous cell carcinoma of oral cavity harboring extracapsular spreading of lymph node s/p adjuvant chemoradiotherapy
| Arm | Type | Receives |
|---|---|---|
| Maintenance | Experimental | Drug: tegafur-uracilEligible patient will be given maintenance tegafur-uracil for one year. Dose of tegafur-uracil will be based on patient's body surface area (BSA): * BSA < 1.5 m2: tegafur-uracil 300 mg/day (1 capsule three times a day) * BSA ≥ 1.5 m2: tegafur-uracil 400 mg/day (2 capsules twice a day) Tegafur-uracil will be started after patient has complete the adjuvant radiotherapy and been enrolled into the study. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient must have histologically confirmed squamous cell carcinoma with primary site in the oral cavity.
- Patient must have no distant metastasis in the pre-adjuvant radiotherapy evaluation.
- Patient must have received surgical treatment with pathologically documented extracapsular spreading of lymph node.
- Patient must have no CTCAE 4.0 grading≧2 acute adverse events from previous definite treatment at enrollment.
- Patient must can be enrolled within 1 to 3 months after definite treatment.
Key exclusion criteria (4 listed)
- Patient who has distant metastasis;
- Patient who has serious concomitant illness which might be aggravated by chemotherapy;
- Other malignancy within 5 years prior to study entry with exception of curative treated basal or squamous cell skin cancer or cervical carcinoma in situ.
- Female patient who is pregnant or breast feeding.
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 |
|---|---|---|
| tegafur-uracilAlso: UFUR | Drug | Maintenance |
Primary outcome
the 2-year distant failure rate
Time frame: 2 years
the 2-year distant failure rate calculated from the date of surgery will be measured
4 secondary outcomes
the 2-year locoregional failure rate.
Time frame: 2 years
the 2-year overall survival (OS) rate
Time frame: 2 years
the 2-year progression-free survival (PFS) rate
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 18165878Liao CT, Chang JT, Wang HM, Ng SH, Hsueh C, Lee LY, Lin CH, Chen IH, Huang SF, Cheng AJ, Yen TC. Analysis of risk factors of predictive local tumor control in oral cavity cancer. Ann Surg Oncol. 2008 Mar;15(3):915-22. doi: 10.1245/s10434-007-9761-5. Epub 2007 Dec 29.
- Background: PubMed 15128893Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
- Background: PubMed 11735172Lam P, Yuen AP, Ho CM, Ho WK, Wei WI. Prospective randomized study of post-operative chemotherapy with levamisole and UFT for head and neck carcinoma. Eur J Surg Oncol. 2001 Dec;27(8):750-3. doi: 10.1053/ejso.2001.1171.
- Background: PubMed 8031158Tsukuda M, Ogasawara H, Kaneko S, Komiyama S, Horiuchi M, Inuyama Y, Uemura T, Uchida M, Kamata S, Okuda M, et al. [A prospective randomized trial of adjuvant chemotherapy with UFT for head and neck carcinoma. Head and Neck UFT Study Group]. Gan To Kagaku Ryoho. 1994 Jul;21(8):1169-77. Japanese.
- Background: PubMed 15128894Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.
- Background: PubMed 20934267Liao CT, Lee LY, Huang SF, Chen IH, Kang CJ, Lin CY, Fan KH, Wang HM, Ng SH, Yen TC. Outcome analysis of patients with oral cavity cancer and extracapsular spread in neck lymph nodes. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):930-7. doi: 10.1016/j.ijrobp.2010.07.1988. Epub 2010 Oct 8.
- 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.
Hung-Ming Wang, M.D. principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tegafur-uracil in people with Squamous Cell Carcinoma of Oral Cavity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 18 inclusion and 4 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 12 Feb 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Hung-Ming Wang, M.D. (+886 33281200 ext. 8820, whm526@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 2-year distant failure rate (time frame: 2 years). 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 NCT03121313, which also lists 6 linked publications.
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 12 Feb 2019.