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Local use of rhGM-CSF + Compound Vitamin B12 solution: The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Radiotherapy: Intensity modulated radiation therapy(IMRT)

Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy.

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Radiotherapy: Intensity modulated radiation therapy(IMRT)

Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy.

The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.

rhGM-CSF

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Compound Vitamin B12

Wei LUO, M.D.

This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.

Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
4. KPS≥70.
5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
4. Diarrhea.

Outcome measures:

1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0
2. Pain: WHO,Numerical Rating Scale(NRS)
3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

A Open,Randomized Phase II Trial Comparing Local Use of rhGM-CSF and Compound Vitamin B12 Solution to Compound Vitamin B12 Solution Alone Treating Chemoradiotherapy-induced Oral Mucositis in Patients With Primary Nasopharyngeal Carcinoma

Cumulative incidence and time of different grade,using the criteria of WHO,NRS

Cumulative incidence and time of different grade,using NCI CTCAE v3.0

Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)

Wei LUO

Professor

Fluorouracil

Induction chemotherapy (Docetaxel + Cisplatin + 5-FU):

* Docetaxel 75 mg/m² administered on D1 of each course, every 3 weeks, via one-hour IV infusion
* Cisplatin 75 mg/m² administered on D1 via one-hour infusion followed by
* 5-Fluorouracil (as a continuous infusion): 750 mg/m²/d administered as a continuous infusion from D1 to D5.

The cycles will be repeated every 3 weeks up to a total of 3 courses. Followed by concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Concurrent chemoradiotherapy with Cisplatin : weekly Cisplatin 40 mg/m2 starting on D1 of the radiation therapy (70 Gy/7 weeks).

Induction chemotherapy (Docetaxel, Cisplatin and 5-Fluorouracil) + concurrent radiochemotherapy

Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy

Jamel Daoud, Pr

Mounir FRIKHA, Pr

Jean BOURHIS, Pr

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy (Arm A) to concurrent chemoradiotherapy alone (Arm B), in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

The treatments are :

Arm A:

induction chemotherapy: Docetaxel (75 mg/m² administered on D1 of each course, every 3 weeks via one-hour IV infusion) + Cisplatin(75 mg/m² administered on D1 via one-hour infusion )+ 5-FU (750 mg/m²/d administered as a continuous infusion from D1 to D5. The cycles will be repeated every 3 weeks up to a total of 3 courses.

followed by chemoradiotherapy with Cisplatin (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

Arm B: Chemoradiotherapy with Cisplatin alone (40 mg/m2 starting on D1 of the radiation therapy) during 7 weeks

Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers

A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

Groupe Oncologie Radiotherapie Tete et Cou

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis	NCT01806272	Nasopharyngeal ...	rhGM-CSF Compound Vitami...	18 Years - 65 Years	Sun Yat-sen University
Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers	NCT00828386	Nasopharyngeal ...	Induction chemo...	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou
Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers	NCT00828386	Nasopharyngeal ...	Induction chemo...	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou

Spots Global Cancer Trial Database for nasopharyngeal cancers