Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma

NCT ID: NCT03908372

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2025-05-31

Brief Summary

The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.

Detailed Description

The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.

The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.

Conditions

Stage II, III; Nasopharyngeal Squamous Cell Carcinoma; Induction Chemotheray; Concurrent Chemoradiotherapy; Reduce Treatment Intensity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction chemotherapy(IC)+IMRT

Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles

Cisplatin

Intervention Type: DRUG

Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy

IMRT

Intervention Type: RADIATION

IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.

Concurrent chemoradiotherapy(CCRT)

cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy

IMRT

Intervention Type: RADIATION

IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.

Interventions

Docetaxel

Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles

Intervention Type: DRUG

Cisplatin

Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy

Intervention Type: DRUG

IMRT

IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.

Intervention Type: RADIATION

Other Intervention Names

Taxotere; DDP; intensity-modulated radiotherapy

Eligibility Criteria

Inclusion Criteria

• Pathology confirmed nasopharyngeal squamous cell carcinoma.
• Aged 18 to 70 years old;
• Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
• KPS≥70;
• Have measurable lesions on CT/MRI before treatment;
• Treatment for the first time;
• At least 6 months lifetime was expected;
• Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
• Can understand and sign the consent
• Have follow up condition

Exclusion Criteria

• Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
• Previously treatment for cancer
• Pregnant or breeding woman, female without contraception
• Enrolling in other drug trials
• Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
• Without follow up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jun-Lin Yi, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junlin Yi, professor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Chinese Academy of Medical Sciences

Beijin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Junlin Yi, M.D

Role: CONTACT

junlinyi@sohu.com

008601366121799

Facility Contacts

Junlin yi, MD

Role: primary

yijunlin1969@163.com

0086013661217998

References

Xu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20.

Reference Type: BACKGROUND

PMID: 29496056 (View on PubMed)

Liu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z.

Reference Type: BACKGROUND

PMID: 29323141 (View on PubMed)

Yao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6.

Reference Type: BACKGROUND

PMID: 28264724 (View on PubMed)

Xu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28243333 (View on PubMed)

Other Identifiers

NCC1950

Identifier Type: -

Identifier Source: org_study_id