Mucosal MelanomaPhase 2NCT03138642
Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
A Phase 2 study testing RT in people with Mucosal Melanoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range between 20-30%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2010to 30 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed mucosal melanoma of head and neck (MMHN);
- Tumor staged as stages III/IVA (according to the American Joint Committee on Cancer 7th edition staging system) arising from head and neck according to the radiology and clinical exam;
- Prior local resection to primary tumor;
- Radiologically confirmed (MRI, CT or PET-CT if necessary) no regional lymph node present, nor any evidence of distant metastasis;
- Adequate marrow: white blood cell count of 4.0 × 109/L or more; absolute neutrophil of 2.0 × 109/L or more; haemoglobin concentrations of at least 90 g/L; platelet cell count of 100 × 109/L or more；
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2.5×upper limit of normal (ULN)；
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- Adequate renal function: creatinine clearance rate of more than 60 mL/min;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
- Expected lifespan > 3 months;
- Patients must be informed of the investigational nature of this study and give written informed consent；
- Patients must be consent to the follow-up till death, the study termination or the end of the study.
Who cannot join
- Patients with histologically or radiologically distant metastasis or recurrence of primary tumor;
- Any contraception to RT;
- History of previous RT or chemotherapy;
- Any severe previous or intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, serious comorbidities, or had active lupus erythematosus or scleroderma, unstable cardiac disease needing treatment, chronic obstructive pulmonary disease exacerbation or other respiratory illness needing treatment, or an acute or fungal infection requiring treatmen);
- Prior malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- Pregnancy or lactation;
- Unable or unwilling to the compliance of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LiXia Lu
Guangzhou, Guangdong, 510000
Lixia Ly, M.D., China, Guangdong, lulx@sysucc.org.cn
About this study
Official title: A Prospective Phase II Study in Patients With Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical researches are rare and no prospective clinical trial is reported. Surgery is the primary treatment modality for MMHN. However, it is difficult to extend the necessary surgery range for MMHN due to its limitation of being adjacent to the important anatomical structure in head and neck or by the considerations of the protection for organ function. As a result, the recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and find that compared to surgery alone, the addition of post-surgery RT improve the survival; The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is spare for the non-metastatic MMMHN received extended resection to primary tumor. It is necessary to undertake a prospective clinical research for MMHN in the endemic area to estimate efficacy and safety of primary surgery plus postoperative radiotherapy with or without adjuvant chemotherapy, as well as to recognize the risk distribution in this cohort of patients, provide the evidence to improve the stratification treatment strategies in the clinic.
Read the detailed description
All the patients enrolled are confirmed without any evidence of distant metastasis. All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 65-70Gy to CTV1 (high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV. Adjuvant chemotherapy (for example, Temozolomide) is prescribed or not according the consideration of radiation physicians during RT or after RT. The clinical characteristics, radiation dose, chemotherapy regimen and the toxicities of are documented by the radiation physicians.
- Conditions
- Mucosal Melanoma
- Being tested
- RT
- Keywords
- mucosal melanoma, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTRadiation
All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
| Study group | Role | What they receive |
|---|---|---|
| RT | Experimental | The patients are prescribed a EQD2of 65-70Gy to CTV1(high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV. Receives: Radiation: RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
OS is calculated from the first day of therapy to the day of death, or to the last follow-up.
Measured: 3 year
Secondary outcomes (4)
Regional relapse-free survival(RRFS)
RFS is calculated from the first day of therapy to regional failure from any cause. Regional relapses were diagnosed with clinical examination of the neck and, in doubtful cases, by fine needle aspiration or an MRI scan of the neck.
Measured: 3 Year
Local recurrence-free survival(LRFS)
the first day of therapy to local failure from any cause. Local relapses were diagnosed by fibreoptic endoscopy and biopsy.
Measured: 3 Year
Distant metastasis-free survival (DMFS)
DMFS is calculated from the first day of treatment to the date of first remote. Distant metastases were diagnosed by clinical symptoms, physical examinations, and imaging methods that included CT, MRI, bone scan, abdominal sonography, and/or PET-CT.
Measured: 3 Year
Number of participants with adverse events
Number of participants with acute and late toxicity and treatment-related mortality.Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (version 4.0) at each treatment visit, follow-up visit, and at the end of the study.
Measured: 3 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jul 2010
- Primary completion30 May 2017
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixia Lu, Sun Yat-sen University
- Investigators
- LiXia Lu, M.D., Study chair, Sun Yat-sen University Cancer Center,China, GuangdongLiXia Lu, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138642
- Sponsor's protocol ID
- MMHN-01
- Status last verified
- Jan 2018
- First submitted
- 1 May 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandey M, Mathew A, Iype EM, Sebastian P, Abraham EK, Nair KM. Primary malignant mucosal melanoma of the head and neck region: pooled analysis of 60 published cases from India and review of literature. Eur J Cancer Prev. 2002 Feb;11(1):3-10. doi: 10.1097/00008469-200202000-00002.
PubMed 11917203Bishop KD, Olszewski AJ. Epidemiology and survival outcomes of ocular and mucosal melanomas: a population-based analysis. Int J Cancer. 2014 Jun 15;134(12):2961-71. doi: 10.1002/ijc.28625. Epub 2013 Dec 2.
PubMed 24272143McLaughlin CC, Wu XC, Jemal A, Martin HJ, Roche LM, Chen VW. Incidence of noncutaneous melanomas in the U.S. Cancer. 2005 Mar 1;103(5):1000-7. doi: 10.1002/cncr.20866.
PubMed 15651058Benlyazid A, Thariat J, Temam S, Malard O, Florescu C, Choussy O, Makeieff M, Poissonnet G, Penel N, Righini C, Toussaint B, Lacau St Guily J, Vergez S, Filleron T. Postoperative radiotherapy in head and neck mucosal melanoma: a GETTEC study. Arch Otolaryngol Head Neck Surg. 2010 Dec;136(12):1219-25. doi: 10.1001/archoto.2010.217.
PubMed 21173371Owens JM, Roberts DB, Myers JN. The role of postoperative adjuvant radiation therapy in the treatment of mucosal melanomas of the head and neck region. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):864-8. doi: 10.1001/archotol.129.8.864.
PubMed 12925346Wu AJ, Gomez J, Zhung JE, Chan K, Gomez DR, Wolden SL, Zelefsky MJ, Wolchok JD, Carvajal RD, Chapman PB, Wong RJ, Shaha AR, Kraus DH, Shah JP, Lee NY. Radiotherapy after surgical resection for head and neck mucosal melanoma. Am J Clin Oncol. 2010 Jun;33(3):281-5. doi: 10.1097/COC.0b013e3181a879f5.
PubMed 19823070Bibault JE, Dewas S, Mirabel X, Mortier L, Penel N, Vanseymortier L, Lartigau E. Adjuvant radiation therapy in metastatic lymph nodes from melanoma. Radiat Oncol. 2011 Feb 6;6:12. doi: 10.1186/1748-717X-6-12.
PubMed 21294913Ballo MT, Garden AS, Myers JN, Lee JE, Diaz EM Jr, Sturgis EM, Morrison WH, Gershenwald JE, Ross MI, Weber RS, Ang KK. Melanoma metastatic to cervical lymph nodes: Can radiotherapy replace formal dissection after local excision of nodal disease? Head Neck. 2005 Aug;27(8):718-21. doi: 10.1002/hed.20233.
PubMed 15952196Morris KT, Marquez CM, Holland JM, Vetto JT. Prevention of local recurrence after surgical debulking of nodal and subcutaneous melanoma deposits by hypofractionated radiation. Ann Surg Oncol. 2000 Oct;7(9):680-4. doi: 10.1007/s10434-000-0680-y.
PubMed 11034246Frakes JM, Strom TJ, Naghavi AO, Trotti A, Rao NG, McCaffrey JC, Otto KJ, Padhya T, Caudell JJ. Outcomes of mucosal melanoma of the head and neck. J Med Imaging Radiat Oncol. 2016 Apr;60(2):268-73. doi: 10.1111/1754-9485.12404. Epub 2015 Nov 23.
PubMed 26597431Schild SE, Behl D, Markovic SN, Brown PD, Sande JR, Deming RL, Rowland KM Jr, Bearden JD. Brain metastases from melanoma: is there a role for concurrent temozolomide in addition to whole brain radiation therapy? Am J Clin Oncol. 2010 Dec;33(6):633-6. doi: 10.1097/COC.0b013e3181c4c54b.
PubMed 20042969Brachman DG, Pugh SL, Ashby LS, Thomas TA, Dunbar EM, Narayan S, Robins HI, Bovi JA, Rockhill JK, Won M, Curran WP. Phase 1/2 trials of Temozolomide, Motexafin Gadolinium, and 60-Gy fractionated radiation for newly diagnosed supratentorial glioblastoma multiforme: final results of RTOG 0513. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):961-7. doi: 10.1016/j.ijrobp.2014.12.050.
PubMed 25832688Middleton MR, Friedlander P, Hamid O, Daud A, Plummer R, Falotico N, Chyla B, Jiang F, McKeegan E, Mostafa NM, Zhu M, Qian J, McKee M, Luo Y, Giranda VL, McArthur GA. Randomized phase II study evaluating veliparib (ABT-888) with temozolomide in patients with metastatic melanoma. Ann Oncol. 2015 Oct;26(10):2173-9. doi: 10.1093/annonc/mdv308. Epub 2015 Jul 22.
PubMed 26202595Linardou H, Pentheroudakis G, Varthalitis I, Gogas H, Pectasides D, Makatsoris T, Fountzilas G, Bafaloukos D; Hellenic Cooperative Oncology Group. Predictive biomarkers to chemotherapy in patients with advanced melanoma receiving the combination of cisplatin--vinblastine--temozolomide (PVT) as first-line treatment: a study of the Hellenic Cooperative Oncology Group (HECOG). Anticancer Res. 2015 Feb;35(2):1105-13.
PubMed 25667500Guo J, Qin S, Liang J, Lin T, Si L, Chen X, Chi Z, Cui C, Du N, Fan Y, Gu K, Li F, Li J, Li Y, Liang H, Liu J, Lu M, Lu A, Nan K, Niu X, Pan H, Ren G, Ren X, Shu Y, Song X, Tao M, Wang B, Wei W, Wu D, Wu L, Wu A, Xu X, Zhang J, Zhang X, Zhang Y, Zhu H; written on behalf of Chinese Society of Clinical Oncology (CSCO) Melanoma Panel. Chinese Guidelines on the Diagnosis and Treatment of Melanoma (2015 Edition). Chin Clin Oncol. 2016 Aug;5(4):57. doi: 10.21037/cco.2015.12.02. Epub 2015 Dec 17. No abstract available.
PubMed 27164849
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study in Patients With Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era
- ClinicalTrials.gov ID
- NCT03138642
- Acronym / sponsor ID
- MMHN-01
- Conditions
- Mucosal Melanoma
- Keywords
- mucosal melanoma, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 3 May 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.
In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical researches are rare and no prospective clinical trial is reported. Surgery is the primary treatment modality for MMHN. However, it is difficult to extend the necessary surgery range for MMHN due to its limitation of being adjacent to the important anatomical structure in head and neck or by the considerations of the protection for organ function. As a result, the recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and find that compared to surgery alone, the addition of post-surgery RT improve the survival; The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is spare for the non-metastatic MMMHN received extended resection to primary tumor. It is necessary to undertake a prospective clinical research for MMHN in the endemic area to estimate efficacy and safety of primary surgery plus postoperative radiotherapy with or without adjuvant chemotherapy, as well as to recognize the risk distribution in this cohort of patients, provide the evidence to improve the stratification treatment strategies in the clinic.
Detailed description
All the patients enrolled are confirmed without any evidence of distant metastasis. All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 65-70Gy to CTV1 (high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV. Adjuvant chemotherapy (for example, Temozolomide) is prescribed or not according the consideration of radiation physicians during RT or after RT. The clinical characteristics, radiation dose, chemotherapy regimen and the toxicities of are documented by the radiation physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
| Arm | Type | Receives |
|---|---|---|
| RT | Experimental | Radiation: RTThe patients are prescribed a EQD2of 65-70Gy to CTV1(high-risk regions including tumor bed), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT). The Prophylactic irradiation to upper neck is is decided by radiation physicians and given a EQD2 of 70-77Gy to CTVnd (clinically negative lymph nodes), 50-55Gy to CTVn2（neck nodal regions). If there is residual tumor, a EQD2 of 70-77Gy is prescribed to GTV. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically confirmed mucosal melanoma of head and neck (MMHN);
- Tumor staged as stages III/IVA (according to the American Joint Committee on Cancer 7th edition staging system) arising from head and neck according to the radiology and clinical exam;
- Prior local resection to primary tumor;
- Radiologically confirmed (MRI, CT or PET-CT if necessary) no regional lymph node present, nor any evidence of distant metastasis;
- Adequate marrow: white blood cell count of 4.0 × 109/L or more; absolute neutrophil of 2.0 × 109/L or more; haemoglobin concentrations of at least 90 g/L; platelet cell count of 100 × 109/L or more；
Key exclusion criteria (7 listed)
- Patients with histologically or radiologically distant metastasis or recurrence of primary tumor;
- Any contraception to RT;
- History of previous RT or chemotherapy;
- Any severe previous or intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, serious comorbidities, or had active lupus erythematosus or scleroderma, unstable cardiac disease needing treatment, chronic obstructive pulmonary disease exacerbation or other respiratory illness needing treatment, or an acute or fungal infection requiring treatmen);
- Prior malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
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 |
|---|---|---|
| RTAll the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT) | Radiation | RT |
Primary outcome
Overall survival(OS)
Time frame: 3 year
OS is calculated from the first day of therapy to the day of death, or to the last follow-up.
4 secondary outcomes
Regional relapse-free survival(RRFS)
Time frame: 3 Year
Local recurrence-free survival(LRFS)
Time frame: 3 Year
Distant metastasis-free survival (DMFS)
Time frame: 3 Year
Number of participants with adverse events
Time frame: 3 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Background: PubMed 11917203Pandey M, Mathew A, Iype EM, Sebastian P, Abraham EK, Nair KM. Primary malignant mucosal melanoma of the head and neck region: pooled analysis of 60 published cases from India and review of literature. Eur J Cancer Prev. 2002 Feb;11(1):3-10. doi: 10.1097/00008469-200202000-00002.
- Background: PubMed 24272143Bishop KD, Olszewski AJ. Epidemiology and survival outcomes of ocular and mucosal melanomas: a population-based analysis. Int J Cancer. 2014 Jun 15;134(12):2961-71. doi: 10.1002/ijc.28625. Epub 2013 Dec 2.
- Background: PubMed 15651058McLaughlin CC, Wu XC, Jemal A, Martin HJ, Roche LM, Chen VW. Incidence of noncutaneous melanomas in the U.S. Cancer. 2005 Mar 1;103(5):1000-7. doi: 10.1002/cncr.20866.
- Background: PubMed 21173371Benlyazid A, Thariat J, Temam S, Malard O, Florescu C, Choussy O, Makeieff M, Poissonnet G, Penel N, Righini C, Toussaint B, Lacau St Guily J, Vergez S, Filleron T. Postoperative radiotherapy in head and neck mucosal melanoma: a GETTEC study. Arch Otolaryngol Head Neck Surg. 2010 Dec;136(12):1219-25. doi: 10.1001/archoto.2010.217.
- Background: PubMed 12925346Owens JM, Roberts DB, Myers JN. The role of postoperative adjuvant radiation therapy in the treatment of mucosal melanomas of the head and neck region. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):864-8. doi: 10.1001/archotol.129.8.864.
- Background: PubMed 19823070Wu AJ, Gomez J, Zhung JE, Chan K, Gomez DR, Wolden SL, Zelefsky MJ, Wolchok JD, Carvajal RD, Chapman PB, Wong RJ, Shaha AR, Kraus DH, Shah JP, Lee NY. Radiotherapy after surgical resection for head and neck mucosal melanoma. Am J Clin Oncol. 2010 Jun;33(3):281-5. doi: 10.1097/COC.0b013e3181a879f5.
- Background: PubMed 21294913Bibault JE, Dewas S, Mirabel X, Mortier L, Penel N, Vanseymortier L, Lartigau E. Adjuvant radiation therapy in metastatic lymph nodes from melanoma. Radiat Oncol. 2011 Feb 6;6:12. doi: 10.1186/1748-717X-6-12.
- Background: PubMed 15952196Ballo MT, Garden AS, Myers JN, Lee JE, Diaz EM Jr, Sturgis EM, Morrison WH, Gershenwald JE, Ross MI, Weber RS, Ang KK. Melanoma metastatic to cervical lymph nodes: Can radiotherapy replace formal dissection after local excision of nodal disease? Head Neck. 2005 Aug;27(8):718-21. doi: 10.1002/hed.20233.
- Background: PubMed 11034246Morris KT, Marquez CM, Holland JM, Vetto JT. Prevention of local recurrence after surgical debulking of nodal and subcutaneous melanoma deposits by hypofractionated radiation. Ann Surg Oncol. 2000 Oct;7(9):680-4. doi: 10.1007/s10434-000-0680-y.
- Background: PubMed 26597431Frakes JM, Strom TJ, Naghavi AO, Trotti A, Rao NG, McCaffrey JC, Otto KJ, Padhya T, Caudell JJ. Outcomes of mucosal melanoma of the head and neck. J Med Imaging Radiat Oncol. 2016 Apr;60(2):268-73. doi: 10.1111/1754-9485.12404. Epub 2015 Nov 23.
- Background: PubMed 20042969Schild SE, Behl D, Markovic SN, Brown PD, Sande JR, Deming RL, Rowland KM Jr, Bearden JD. Brain metastases from melanoma: is there a role for concurrent temozolomide in addition to whole brain radiation therapy? Am J Clin Oncol. 2010 Dec;33(6):633-6. doi: 10.1097/COC.0b013e3181c4c54b.
- Background: PubMed 25832688Brachman DG, Pugh SL, Ashby LS, Thomas TA, Dunbar EM, Narayan S, Robins HI, Bovi JA, Rockhill JK, Won M, Curran WP. Phase 1/2 trials of Temozolomide, Motexafin Gadolinium, and 60-Gy fractionated radiation for newly diagnosed supratentorial glioblastoma multiforme: final results of RTOG 0513. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):961-7. doi: 10.1016/j.ijrobp.2014.12.050.
- 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.
LiXia Lu, M.D. study chair
Sun Yat-sen University Cancer Center,China, Guangdong
LiXia Lu, M.D. principal investigator
Sun Yat-Sen University Cancer Center
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 RT in people with Mucosal Melanoma, run by Sun Yat-sen University at 1 site in China.
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 11 inclusion and 7 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 30 Jan 2018. 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 China. 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 LiXia Lu, M.D. (+86-20-87343469, lulx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: 3 year). 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 NCT03138642, which also lists 24 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 30 Jan 2018.